Diffuse Cutaneous Systemic SclerosisPhase 1/2BRAVOSNCT03222492

Brentuximab Vedotin for Systemic Sclerosis

A Phase 1/2 study testing Brentuximab Vedotin in people with Diffuse Cutaneous Systemic Sclerosis and Scleroderma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
What is being tested?: Brentuximab Vedotin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 8 sitesUnited States
Study dates: 20 Sep 2017to 10 Apr 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Classification of Systemic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/European Union League Against Rheumatism classification of SSc;
Diagnosis of Diffuse Cutaneous Systemic Sclerosis (dcSSc), as defined by LeRoy and Medsger, Criteria for the classification of early systemic sclerosis. J Rheumatol, 2001. 28(7): p. 1573-6;
Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation);
Modified Rodnan Skin Score (mRSS) units ≥ 15 and ≤ 45, and both of the following:
At least mild skin thickening (≥ 1+ mRSS) of the forearm, and
At least moderate skin thickening (≥ 2+ mRSS) at the planned forearm skin biopsy site.

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Documentation of at least 12 weeks of ongoing immunosuppressive therapy for SSc at the time of enrollment, and at least 4 weeks at a stable dose, of one of the following:
Methotrexate ≤ 25 mg/week, or
Mycophenolate mofetil ≤3 grams/day or mycophenolate sodium ≤2.16 grams/day, or
Azathioprine ≤3mg/kg/day.
Ability to provide informed consent.

Who cannot join

Rheumatic disease other than Diffuse Cutaneous Systemic Sclerosis (dcSSc); it is acceptable to include patients with osteoarthritis, fibromyalgia, sicca symptoms, and scleroderma-associated myopathy;
Limited cutaneous Systemic Sclerosis (SSc) or sine scleroderma;
Pulmonary disease with Forced Vital Capacity (FVC) ≤60% of predicted, or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin) ≤60% of predicted;
Pulmonary hypertension (PH) or moderate to severe left ventricular dysfunction, defined as one of the following:
Transthoracic echocardiography demonstrating at least one of the following (unless subsequent right heart catheterization does not demonstrate PH; or unless prior right heart catheterization within one year did not demonstrate PH and echocardiography results are not significantly changed):
Tricuspid regurgitation jet >2.8 m/sec or estimated right ventricular systolic pressure > 42 mm Hg. or

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At least one of the following:
Abnormality of right atrial size, shape, or wall thickness consistent with PH, or
Abnormality of right ventricular size, shape, or wall thickness consistent with PH, or
Abnormal septal wall shape consistent with PH.
Left Ventricular Ejection Fraction (LVEF) <50%.
Right heart catheterization showing mean pulmonary artery pressure ≥25 mm Hg at rest;
Current use of approved medications for PH. It is acceptable to use phosphodiesterase type 5 (PDE-5) inhibitors for Raynaud's, digital ulcers, and intermittently for erectile dysfunction.
Active scleroderma renal crisis within the 4 months prior to enrollment;
History of moderate-to-severe lower gastrointestinal dysmotility such as current use of parenteral nutrition and/or recent history of intestinal pseudo-obstruction within 3 months prior to enrollment;
The following medications:
Oral corticosteroids >10 mg/day of prednisone or equivalent within 2 weeks prior to enrollment;
Treatment with Intravenous Immunoglobulin (IVIG) within 12 weeks prior to enrollment;
Treatment with cyclophosphamide within 6 months prior to enrollment;
Use of investigational biologic or non-biologic medication within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
Use of anti-TNF medication or other biologic medications within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
Prior treatment with anti-CD20 if either of the following are true:
B cells ≤ lower limit of normal (LLN), or
Treatment with anti-CD20 has been within 12 months prior to enrollment.
Any prior treatment with cell-depleting therapies other than anti-CD20, including investigational agents, including but not limited to, CAMPATH(R), anti- CD4, anti-CD5, anti-CD3, anti-CD19; or
Any prior treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.
Receipt of a live-attenuated vaccine within 3 months of study enrollment;
Concomitant malignancies or a history of malignancy, with the exception of adequately treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;
Major surgery (including joint surgery) within 8 weeks prior to enrollment;
History of solid organ or hematopoietic stem cell transplantation;
History of primary immunodeficiency;
Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to enrollment;
Current substance abuse or history of substance abuse within 12 months prior to enrollment;
History of severe depression or severe psychiatric condition;
Lack of peripheral venous access;
Known hypersensitivity to brentuximab vedotin, a component thereof, or the excipient contained in the drug formulation;
Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study), including but not limited to:
Uncompensated congestive heart failure (New York Heart Association Class III or VI);
Clinically significant active coronary artery disease (e.g., unstable angina or acute myocardial infarction within 6 months prior to enrollment);
Recently active cerebrovascular disease (e.g., stroke or transient ischemic attack within 6 months prior to enrollment);
Uncontrolled systemic hypertension;
Confirmed diagnosis of diabetes mellitus;
Pancreatitis within 30 days prior to enrollment; or
History or presence of peripheral neuropathy, such as mononeuritis multiplex, acute or chronic inflammatory demyelinating polyneuropathy, axonal sensorimotor neuropathies, or drug related neuropathy or neuritis.
Evidence of infection:
Any infected ulcer at enrollment;
Active bacterial, viral, fungal, or opportunistic infections requiring systemic anti-infective therapy;
Evidence of current or prior infection with tuberculosis:
Positive QuantiFERON® - TB Gold or TB Gold Plus test results.
Note: Purified protein derivative (PPD) tuberculin test may be substituted for QuantiFERON® - TB Gold or TB fold Plus test.
Indeterminant QuantiFERON® - TB Gold test results, unless followed by a subsequent negative PPD or negative QuantiFERON® and clearance by local Infectious Disease department.
Evidence of current or prior infection with:
Human Immunodeficiency Virus (HIV), or
Hepatitis B Virus (as assessed by hepatitis B surface antigen, HBsAg and antibody to hepatitis B core antigen, anti-HBc), or
Hepatitis C Virus (HCV), with the exception of adequately treated HCV with documentation of sustained virologic response, defined as undetectable HCV RNA at least 12 weeks after the end of treatment.
History of progressive multifocal leukoencephalopathy (PML);
Hospitalization for treatment of infections, or parenteral (intravenous or intramuscular) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within the past 60 days prior to enrollment;
Chronic infection that is currently being treated with systemic suppressive antibiotic or antiviral therapy, including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria.
History of significant infection or recurrent infection that, in the investigator's opinion, places the participant at risk by participating in this study.
Positive polymerase chain reaction (PCR) test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) within 14 days prior to enrollment.
The following laboratory abnormalities:
Neutropenia (absolute neutrophil count <1500/mm^3);
Thrombocytopenia (platelets <100,000/mm^3);
Moderately severe anemia (hemoglobin, Hgb < 10 g/dL);
Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are ≥ 1.5 times the upper limit of normal;
Serum total bilirubin > 1.5 times the upper limit of normal, or > 3 times the upper limit of normal in the presence of Gilbert's syndrome; or
Serum amylase and serum lipase > 1.5 times the upper limit of normal.
Renal dysfunction, defined as either one of the following:
Serum creatinine > 1.5 times the upper limit of normal; or
Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2.
Pregnancy;
Breastfeeding;
Unwillingness to use two forms of medically acceptable contraception methods by participants and their partners (if of reproductive potential) during the study and for at least 6 months after last dose of study drug; or
Inability to comply with study and follow-up procedures.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Ann Arbor, Michigan, 48109
Medical University of South Carolina: Division of Rheumatology & Immunology
Charleston, South Carolina, 29425
Duke University Medical Center: Division of Rheumatology and Immunology
Durham, North Carolina, 27710
University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030
UCLA Medical Center: Division of Rheumatology
Los Angeles, California, 90095
Hospital for Special Surgery, New York: Division of Rheumatology
New York, New York, 10021
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical
Pittsburgh, Pennsylvania, 15217
Georgetown University Medical Center: Division of Rheumatology
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)

Read the detailed description

This is a multicenter prospective double blind placebo controlled dose escalation safety clinical trial with brentuximab vedotin and stable background immunosuppressive therapy in adult individuals with Diffuse Cutaneous Systemic Sclerosis (dcSSc). Adult male and female participants with dcSSc will be recruited by a collaborative group of clinical sites in the United States. Participants who meet the eligibility criteria will be enrolled without regard to gender, race, or ethnicity.

Eligible participants will be randomly assigned to study treatment, either brentuximab vedotin or placebo equivalent in a 6:2 ratio favoring brentuximab vedotin. Three dose cohorts are planned with 8 participants in each cohort, for a total of 24 participants who receive sufficient doses of the investigational medication to assess safety.

The doses planned for each ascending dose cohort include 0.6mg/kg, 1.2 mg/kg, and 1.8 mg/kg brentuximab vedotin or placebo equivalent. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses. Following completion of treatment, participants will undergo follow-up visits at weeks 24, 28, 36 and 48.

Conditions: Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
Being tested: Brentuximab Vedotin, Placebo
Keywords: Diffuse Cutaneous Systemic Sclerosis (dcSSc), Phase 1/2 clinical trial, dose escalation randomized trial, Brentuximab vedotin
Medical subject headings: Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brentuximab VedotinBiological
Also called Adcetris®
Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.
PlaceboBiological
Also called Placebo for brentuximab vedotin
Placebo control for blinding (masking), 0.95% normal saline.

Study groups in NCT03222492
Study group	Role	What they receive
Cohort 1: 0.6 mg/kg brentuximab vedotin	Experimental	This is the first of three ascending dose cohorts. Participants in this cohort will receive 0.6 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Brentuximab Vedotin
Cohort 1: placebo	Placebo comparator	0.6 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 0.6 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Placebo
Cohort 2: 1.2 mg/kg brentuximab vedotin	Experimental	This is the second of three ascending dose cohorts. Participants in this cohort will receive 1.2 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Brentuximab Vedotin
Cohort 2: placebo	Placebo comparator	1.2 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.2 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Placebo
Cohort 3: 1.8 mg/kg brentuximab vedotin	Experimental	This is the third/last of three ascending dose cohorts. Participants in this cohort will receive 1.8 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Brentuximab Vedotin
Cohort 3: placebo	Placebo comparator	1.8 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.8 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through end of study (48 weeks for participants who complete the study)
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through end of study (48 weeks)

Secondary outcomes (20)

Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 48.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.
Measured: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Any of the Following Grade 3 or Higher AEs at or Before Week 48: Peripheral Neuropathy, Neutropenia, Infectious Adverse Events, Infusions Reactions, or Progressive Multifocal Leukoencephalopathy.
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Measured: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201710 Apr 2023

First posted19 Jul 2017
Study start20 Sep 2017
Primary completion10 Apr 2023
Study completion10 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03222492
Sponsor's protocol ID: DAIT ITN075AI
Other IDs: UM1AI109565, NIAID CRMS ID#: 38418
Acronym: BRAVOS
Status last verified: Apr 2026
First submitted: 17 Jul 2017
Last updated: 5 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diffuse Cutaneous Systemic Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)
ClinicalTrials.gov ID: NCT03222492
Acronym / sponsor ID: BRAVOS / DAIT ITN075AI
Conditions: Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
Keywords: Diffuse Cutaneous Systemic Sclerosis (dcSSc), Phase 1/2 clinical trial, dose escalation randomized trial, Brentuximab vedotin
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Immune Tolerance Network (ITN), Seagen Inc., PPD Development, LP, Rho Federal Systems Division, Inc.
Study start: 20 Sep 2017 (actual)
Primary completion: 10 Apr 2023 (actual)
Study completion: 10 Apr 2023 (actual)
First posted: 19 Jul 2017 (actual)
Results: Posted 17 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1: 0.6 mg/kg brentuximab vedotin	Experimental	Biological: Brentuximab VedotinThis is the first of three ascending dose cohorts. Participants in this cohort will receive 0.6 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Cohort 1: placebo	Placebo comparator	Biological: Placebo0.6 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 0.6 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Cohort 2: 1.2 mg/kg brentuximab vedotin	Experimental	Biological: Brentuximab VedotinThis is the second of three ascending dose cohorts. Participants in this cohort will receive 1.2 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Cohort 2: placebo	Placebo comparator	Biological: Placebo1.2 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.2 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Cohort 3: 1.8 mg/kg brentuximab vedotin	Experimental	Biological: Brentuximab VedotinThis is the third/last of three ascending dose cohorts. Participants in this cohort will receive 1.8 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Cohort 3: placebo	Placebo comparator	Biological: Placebo1.8 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.8 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Classification of Systemic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/European Union League Against Rheumatism classification of SSc;
Diagnosis of Diffuse Cutaneous Systemic Sclerosis (dcSSc), as defined by LeRoy and Medsger, Criteria for the classification of early systemic sclerosis. J Rheumatol, 2001. 28(7): p. 1573-6;
Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation);
Modified Rodnan Skin Score (mRSS) units ≥ 15 and ≤ 45, and both of the following:
Documentation of at least 12 weeks of ongoing immunosuppressive therapy for SSc at the time of enrollment, and at least 4 weeks at a stable dose, of one of the following:

Key exclusion criteria (74 listed)

Rheumatic disease other than Diffuse Cutaneous Systemic Sclerosis (dcSSc); it is acceptable to include patients with osteoarthritis, fibromyalgia, sicca symptoms, and scleroderma-associated myopathy;
Limited cutaneous Systemic Sclerosis (SSc) or sine scleroderma;
Pulmonary disease with Forced Vital Capacity (FVC) ≤60% of predicted, or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin) ≤60% of predicted;
Pulmonary hypertension (PH) or moderate to severe left ventricular dysfunction, defined as one of the following:
Active scleroderma renal crisis within the 4 months prior to enrollment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brentuximab VedotinAlso: Adcetris®Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.	Biological	Cohort 1: 0.6 mg/kg brentuximab vedotin, Cohort 2: 1.2 mg/kg brentuximab vedotin, Cohort 3: 1.8 mg/kg brentuximab vedotin
PlaceboAlso: Placebo for brentuximab vedotinPlacebo control for blinding (masking), 0.95% normal saline.	Biological	Cohort 1: placebo, Cohort 2: placebo, Cohort 3: placebo

Primary outcome

Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
Time frame: Baseline through end of study (48 weeks for participants who complete the study)
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
Time frame: Baseline through end of study (48 weeks)
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

20 secondary outcomes

Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.
Time frame: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12
Time frame: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.
Time frame: Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.
Time frame: Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.
Time frame: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12
Time frame: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.
Time frame: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.
Time frame: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48.
Time frame: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48.
Time frame: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12
Time frame: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24.
Time frame: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36.
Time frame: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48.
Time frame: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48.
Time frame: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12
Time frame: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24.
Time frame: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36.
Time frame: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 48.
Time frame: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Any of the Following Grade 3 or Higher AEs at or Before Week 48: Peripheral Neuropathy, Neutropenia, Infectious Adverse Events, Infusions Reactions, or Progressive Multifocal Leukoencephalopathy.
Time frame: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Results and safety

Results posted to the registry on 17 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Brentuximab Vedotin	6	6
Cohort 1 Placebo	2	2
Cohort 2 Brentuximab Vedotin	7	5
Cohort 2 Placebo	2	2

Primary outcome: Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.

Time frame: Baseline through end of study (48 weeks for participants who complete the study). Number (95% Confidence Interval). Unit: Proportion of participants

Measure	0.6 mg/kg Brentuximab Vedotin n = 6	0.6 mg/kg Placebo n = 2	1.2 mg/kg Brentuximab Vedotin n = 7	1.2 mg/kg Placebo n = 2	Brentuximab Vedotin in Pooled Participants n = 13	Placebo in Pooled Participants n = 4
Value	0.333 (0.043 to 0.777)	0.000 (0.000 to 0.842)	0.571 (0.184 to 0.901)	0.000 (0.000 to 0.842)	0.462 (0.192 to 0.749)	0.000 (0.000 to 0.602)

0.6 mg/kg Brentuximab Vedotin vs 0.6 mg/kg Placebo: p = 1.000, Fisher Exact
1.2 mg/kg Brentuximab Vedotin vs 1.2 mg/kg Placebo: p = 0.444, Fisher Exact

Population analysed: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Primary outcome: Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.

Time frame: Baseline through end of study (48 weeks). Number (95% Confidence Interval). Unit: proportion of participants

Measure	0.6 mg/kg Brentuximab Vedotin n = 5	0.6 mg/kg Placebo n = 2	1.2 mg/kg Brentuximab Vedotin n = 3	1.2 mg/kg Placebo n = 2	Brentuximab Vedotin in Pooled Participants n = 8	Placebo in Pooled Participants n = 4
Value	0.400 (0.053 to 0.853)	0.000 (0.000 to 0.842)	0.667 (0.094 to 0.992)	0.000 (0.000 to 0.842)	0.500 (0.157 to 0.843)	0.000 (0.000 to 0.602)

0.6 mg/kg Brentuximab Vedotin vs 0.6 mg/kg Placebo: p = 1.000, Fisher Exact
1.2 mg/kg Brentuximab Vedotin vs 1.2 mg/kg Placebo: p = 0.400, Fisher Exact

Population analysed: The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.6 mg/kg Brentuximab Vedotin	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
0.6 mg/kg Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
1.2 mg/kg Brentuximab Vedotin	2 of 7 (28.6%)	6 of 7 (85.7%)	0 of 7
1.2 mg/kg Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Brentuximab Vedotin in Pooled Participants	3 of 13 (23.1%)	12 of 13 (92.3%)	0 of 13
Placebo in Pooled Participants	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): Due to slow enrollment the study was stopped before fully enrolling cohort 2 (1.2 mg/kg) and before starting cohort 3 (1.8 mg/kg).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
Immune Tolerance Network (ITN)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dinesh Khanna, MD, MSc study chair

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

David Fox, MD study chair

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 74 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48. (time frame: Baseline through end of study (48 weeks for participants who complete the study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.