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Graft FailurePhase 2NCT04731298

Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.

A Phase 2 study testing Emapalumab in people with Graft Failure, run by Swedish Orphan Biovitrum at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria will be eligible to receive emapalumab. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Graft Failure
What is being tested?
Emapalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
5 sitesin 3 countries
Study dates
25 May 2021to 21 Apr 2022
Phase
Phase 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 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Informed consent form signed by the patient (as required by law) or by the patient's legally authorized representative(s) with the assent of patients who are legally capable of providing it, as applicable
  • Recipients of allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and at high risk of graft failure (GF) based on at least one of the following criteria:
  • Receiving reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA) combined with a non-malignant disease or with a graft from Bone Marrow (BM)
  • Ex vivo T cell depleted graft
  • Graft from mismatched unrelated or haploidentical donor
  • Graft from Umbilical Cord Blood (UCB)
Show all 12Show fewer
  • Patients requiring allo-HSCT with the following underlying diseases:
  • Malignant disease with high risk of GF, i.e. Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) with primary induction failure, second partial remission or relapse; Chronic Myeloid Leukemia (CML) in blastic phase (circulating blast or blast above 5% in biopsy); Non Hodgkin and Hodgkin Lymphoma and multiple myeloma with primary induction failure, second partial remission or relapse, myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) with splenomegaly, myelofibrosis with portal hypertension pre-transplant, MDS/MPD overlap syndromes
  • Non-malignant hematological diseases (e.g. autoimmune and metabolic disorders, aplastic anemia, Sickle cell anemia, Fanconi anemia, Diamond-Blackfan anemia, thalassemia, osteopetrosis, Wiskott-Aldrich syndrome, severe combined immunodeficiency, Hemophagocytic lymphohistiocytosis and other immunoregulatory disorders)
  • Male and female patients
  • Children aged at least 1 year and adults. Once the appropriate dose has been determined in one of the three cohorts and safety has been assessed by the Independent Data Monitoring Committee (IDMC), children less than 1 year old may be included in the study.
  • Females of child-bearing potential, defined as all women physiologically capable of becoming pregnant, require use of highly effective contraceptive measures from screening until 6 months after the last study drug administration

Who cannot join

  • Pregnant (or planning to become pregnant) or lactating female patients
  • Body weight < 3 kg
  • Underlying malignant disease with Karnofsky/Lansky performance status equal or less than 40 or an Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 3
  • Patients presenting CXCL9 levels 10 times above the upper limit of the 95% interval (CI) of the normal range (reported in the CXCL9 assay laboratory manual) within 24 hours prior to HSCT
  • Clinically manifested infections caused by typical and atypical Mycobacteria, Salmonella, Histoplasma capsulatum and Herpes Zoster on the day of HSCT
  • Active or clinical suspicion of latent tuberculosis
Show all 16Show fewer
  • Concomitant diseases that in the opinion of the Investigator may interfere with the assessment of emapalumab safety or efficacy
  • Receipt of a Bacille Calmette-Guerin (BCG) vaccine within 3 months prior to HSCT
  • Receipt of a live or attenuated live (other than BCG) vaccine within 6 weeks prior to HSCT
  • Current or scheduled administration of therapies known to potentially trigger a cytokine release syndrome within 21 days from HSCT.
  • Patients having received IFNγ during the last 2 weeks prior to HSCT and/or who require treatment with IFNγ.
  • Patients having received emapalumab during the last 6 months prior to HSCT, unless it is known that emapalumab is no longer detectable.
  • Patients having received kinase inhibitors (Janus kinase inhibitors [JAKi] or bruton tyrosine kinase inhibitors [BTKi]) one week (or 5 half-lives whichever is greater) prior to HSCT.
  • Intolerance to antimicrobial and virus infection prophylaxis.
  • Hypersensitivity to emapalumab or any of the excipients.
  • Ongoing participation in an interventional trial or administration of any investigational drug (within 3 half-lives of the investigational drug) with the exception of interventional trials involving supportive care such as probiotics or antiemetics, graft manipulation, or use of new combinations or new dosing of conventional therapies for conditioning and prophylaxis pre-HSCT.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Kids Cancer Centre Sydney Children's Hospital

    Randwick, 2031

Other trials in Australia

Israel2 sites

  • The Rambam Academic Hospital

    Haifa, 31096

  • Hadassah Hebrew University

    Jerusalem, 91120

Other trials in Israel

Canada1 site

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

Official title: An Open Label, Single Arm, Multicentre, Proof of Concept, Phase 2 Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After Allogeneic Hematopoietic Stem Cell Transplantation

This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria will be eligible to receive emapalumab.

Both children and adults, with malignant and non-malignant underlying diseases, receiving allo-HSCT who are at high risk of GF as defined in the inclusion criteria will be included in the study. The main objective of the study is to determine the appropriate emapalumab dose regimen neutralizing interferon gamma (IFNγ) activity to pre-empt graft failure post allo-HSCT in a population with various underlying diseases and at high risk of graft failure (GF).

Read more

Maximum 3 cohorts are foreseen to determine the appropriate dose regimen to pre-emptively treat patients at risk of primary GF.

Emapalumab will be administered by IV infusion and treatment will last up to 56 days (15 infusions) or until evidence of engraftment.

The study is expected to last approximately 3 years from screening to the last follow-up phone call for each patient.

Read the detailed description

This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria will be eligible to receive emapalumab.

Both children and adults, with malignant and non-malignant underlying diseases, receiving allo-HSCT who are at high risk of GF as defined in the inclusion criteria will be included in the study. The main objective of the study will be to determine the appropriate emapalumab dose regimen neutralizing interferon gamma (IFNγ) activity to pre-empt graft failure post allo-HSCT in a population with various underlying diseases and at high risk of graft failure (GF).

Maximum 3 cohorts are foreseen to determine the appropriate dose regimen to pre-emptively treat patients at risk of primary GF.

Emapalumab will be administered by IV infusion over 1 to 2 hours depending on the volume of the infusion. Treatment will last up to 56 days (15 infusions) or until evidence of engraftment.

The study is comprised of the following study periods: screening (Day -21 to Day -8), allogeneic HSCT Day 0, monitoring period for primary GF (Day 1 up to Day 42), extended monitoring for secondary GF (up to Day 98), treatment period (up to 56 days) and follow-up period of 3 years after HSCT.

The main objective of this proof of concept study is:

  • To determine the appropriate emapalumab dose regimen neutralizing interferon gamma (IFNγ) activity to pre-empt graft failure post allogeneic hematopoietic stem cell transplantation (HSCT) in a population with various underlying diseases and at high risk of graft failure (GF)

The following objectives will support the dose selection:

  • To describe the Pharmacokinetic (PK) and Pharmacodynamic (PD) profiles of emapalumab post allogeneic HSCT (allo-HSCT)
  • To assess the efficacy of emapalumab to pre-empt GF post allo-HSCT
  • To assess the safety of emapalumab to pre-empt GF post allo-HSCT
  • To assess the immunogenicity of emapalumab post allo-HSCT

Exploratory objectives will be:

  • To evaluate further data on the correlation between relevant biomarkers including C-X-C motif chemokine ligand 9 (CXCL9) levels and the risk of GF post allo-HSCT in a population with various underlying diseases and at high risk of GF also in the context of development of a diagnostic test.

The study is expected to last approximately 3 years from screening to the last follow-up phone call for each patient.

Conditions
Graft Failure
Being tested
Emapalumab
Keywords
HSCT, allo-HSCT, Graft failure, emapalumab, interferon gamma, CXCL9

What participants receive

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

  • EmapalumabDrug

    Also called Gamifant®, NI-0501

    Emapalumab is a fully human immunoglobulin G1 (IgG1) anti-IFNγ monoclonal antibody that binds to and neutralizes IFNγ. Emapalumab binds to both soluble and receptor (IFNγR1)-bound forms of IFNγ.

    Emapalumab is in development for treatment of primary and secondary HLH. The benefit expected from the targeted neutralization of IFNγ by emapalumab has been validated by the recent FDA approval of emapalumab for treatment of patients with pHLH who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The safety profile has been assessed as acceptable.

    Emapalumab will be administered by intravenous infusion over 1 to 2 hours, depending on the volume of the infusion. The first infusion must be performed within 12 hours after CXCL9 levels have been measured above defined threshold. Treatment will last until maximum dose 15 (up to 56 days) or until evidence of engraftment, whichever comes first.

Study groups in NCT04731298
Study groupRoleWhat they receive
EmapalumabExperimentalThe first cohort of patients will receive a first infusion of 6 mg/kg at TD0, followed by a second infusion at 3 mg/kg after 3 days (treatment day 3 - TD3). Subsequent infusions of 3 mg/kg will be every 3 or 4 days from previous dose until dose 15 or until engraftment. A maximum of 2 additional cohorts may be added to allow dosing regimen adaptation based on the PK/PD data observed from the previous cohort(s). Efficacy and safety data will also be considered before adding additional cohorts.
Receives: Drug: Emapalumab

What is being measured

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

  1. CXCL9 in Serum

    Serum concentration of C-X-C Motif Chemokine Ligand 9 (CXCL9)

    Measured: From start of treatment to EoS Visit, up to 34 weeks

  2. Primary Graft Failure (GF)

    Number of participants with primary graft failure (GF)

    Measured: From Hematopoietic stem-cell transplantation (HSCT) [Day 0] up to study termination, approximately 46 weeks

  3. Secondary GF

    Number of participants with secondary GF

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

Secondary outcomes (60)

  1. Free & Total Interferon Gamma (IFNγ) in Serum

    Serum concentration of free and total Interferon gamma (IFNγ)

    Measured: From start of treatment to EoS Visit, up to 34 weeks

  2. Emapalumab in Serum - Peak

    Peak emapalumab serum concentration

    Measured: From start of treatment to EoS, up to 34 weeks

  3. Ctrough (Emapalumab)

    Concentration just before administration

    Measured: From start of treatment to EoS, up to 34 weeks

  4. Exploratory Biomarkers: Ferritin

    Ferritin - serum concentration

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  5. ADA and nAbs

    Number of participants developing antibodies against emapalumab (antidrug antibodies [ADA]) and Neutralizing antibodies (nAb)

    Measured: From Start of treatment until EoS, up to 34 weeks

  6. Number of Participants With Mixed Donor Chimerism <10% and <20%

    Based on unselected leukocytes and based on sorted T cells

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  7. Number of Participants Receiving Thrombopoietic Agents, Stem Cell Boost, Donor Lymphocyte Infusion (DLI)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  8. Number of Participants Receiving a Second Allogeneic HSCT

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  9. Number of Participants With Poor Graft Function

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  10. Number of Participants With Event Free Engraftment

    defined as absence of GF or graft support

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  11. Number of Participants With Acute and/or Chronic Mild to Severe Graft Versus Host Disease (GvHD)

    (grade I to IV)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  12. Biomarker Levels, in Particular IFNy and CXCL9, as Predictors of Primary and/or Secondary Graft Failure or Acute and/or Chronic GvHD

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  13. Engraftment Syndrome

    Number of participants with engraftment syndrome

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  14. Number of Participants With Endothelial Complications

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  15. Number of Participants With Relapse, Defined as Cumulative Incidence of Reoccurring Underlying Disease

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  16. Survival Rate

    Number of patients alive at the end of study.

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  17. Change in Body Temperature

    Change from baseline in body temperature

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  18. Change in Heart Rate

    Change from baseline in heart rate

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  19. Change in Blood Pressure

    Change from baseline systolic and diastolic blood pressure

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  20. Change in Body Weight

    Change from baseline in body weight

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  21. Change in Hematology: Red Blood Cells (RBC)

    Change from baseline in Hematology: red blood cells (RBC)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  22. Change in Hematology: Hematocrit

    Change from baseline in Hematology: hematocrit

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  23. Change in Hematology: Hemoglobin

    Change from baseline in Hematology: hemoglobin

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  24. Change in Hematology: Platelets

    Change from baseline in Hematology: platelets

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  25. Change in Hematology: White Blood Cells (WBC)

    Change from baseline in Hematology: white blood cells (WBC)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  26. Change in Hematology Differential: Lymphocytes

    Change from baseline in Hematology differential: lymphocytes

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  27. Change in Hematology Differential: Monocytes

    Change from baseline in Hematology differential: monocytes

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  28. Change in Hematology Differential: Neutrophils

    Change from baseline in Hematology differential: neutrophils

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  29. Change in Biochemistry: Ferritin

    Change from baseline in Biochemistry: Ferritin

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  30. Change in Biochemistry: Glucose

    Change from baseline in Biochemistry: Glucose

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  31. Change in Biochemistry: C-reactive Protein

    Change from baseline in Biochemistry: C-reactive protein

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  32. Change in Biochemistry: Sodium

    Change from baseline in Biochemistry: Sodium

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  33. Change in Biochemistry: Potassium

    Change from baseline in Biochemistry: Potassium

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  34. Change in Biochemistry: Chloride

    Change from baseline in Biochemistry: Chloride

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  35. Change in Biochemistry: Calcium

    Change from baseline in Biochemistry: Calcium

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  36. Change in Biochemistry: Magnesium

    Change from baseline in Biochemistry: Magnesium

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  37. Change in Biochemistry: Phosphate

    Change from baseline in Biochemistry: Phosphate

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  38. Change in Biochemistry: Aspartate Aminotransferase (AST)

    Change from baseline in Biochemistry: Aspartate aminotransferase (AST)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  39. Change in Biochemistry: Alanine Aminotransferase (ALT)

    Change from baseline in Biochemistry: alanine aminotransferase (ALT)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  40. Change in Biochemistry: Gamma-glutamyl Transpeptidase (γGT)

    Change from baseline in Biochemistry: gamma-glutamyl transpeptidase (γGT)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  41. Change in Biochemistry: Alkaline Phosphatase (ALP)

    Change from baseline in Biochemistry: alkaline phosphatase (ALP)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  42. Change in Biochemistry: Lactate Dehydrogenase (LDH)

    Change from baseline in Biochemistry: lactate dehydrogenase (LDH)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  43. Change in Biochemistry: Bilirubin

    Change from baseline in Biochemistry: bilirubin (total, direct and indirect)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  44. Change in Biochemistry: Triglycerides

    Change from baseline in Biochemistry: triglycerides

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  45. Change in Biochemistry: Cholesterol

    Change from baseline in Biochemistry: cholesterol (total and high-density lipoprotein [HDL])

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  46. Change in Biochemistry: Albumin

    Change from baseline in Biochemistry: Albumin

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  47. Change in Biochemistry: Creatinine

    Change from baseline in Biochemistry: Creatinine

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  48. Change in Biochemistry: Urea

    Change from baseline in Biochemistry: Urea

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  49. Activated Partial Thromboplastin (aPTT)

    Change from baseline in Coagulation: activated partial thromboplastin (aPTT)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  50. Prothrombin Time (PT)

    Change from baseline in Coagulation: prothrombin time (PT)

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  51. Change in Urinalysis: Glucose

    Change from baseline in Urinalysis: Glucose

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  52. Change in Urinalysis: Blood

    Change from baseline in Urinalysis: Blood

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  53. Change in Urinalysis: Protein

    Change from baseline in Urinalysis: Protein

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  54. Change in Urinalysis: Leucocytes

    Change from baseline in Urinalysis: Leucocytes

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  55. Change in Urinalysis: Ketones

    Change from baseline in Urinalysis: Ketones

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  56. Change in Urinalysis: pH

    Change from baseline in Urinalysis: pH

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  57. Change in Urinalysis: Specific Gravity

    Change from baseline in Urinalysis: specific gravity

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  58. Number of Subjects With Change in Donor Chimerism

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  59. Change in HLA Antibodies

    Change from baseline in HLA antibodies against donor cells

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

  60. Change From Baseline in Minimal Residual Disease (MRD)

    Only in patients presenting malignant disease

    Measured: From HSCT (Day 0) up to study termination, approximately 46 weeks

Timeline

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

  1. First posted29 Jan 2021
  2. Study start25 May 2021
  3. Primary completion21 Apr 2022
  4. Study completion21 Apr 2022

Why it stopped: Sponsor Decision related to Business Priorities, Assessment of Development Options

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequential dose cohorts. The first cohort of patients will receive a first emapalumab infusion of 6 mg/kg at TD0, followed by a second infusion at 3 mg/kg after 3 days. Subsequent infusions of 3 mg/kg will be every 3 or 4 days from previous dose until dose 15 or until engraftment. A maximum of 2 additional cohorts may be added to allow dosing regimen adaptation based on the PK/PD data observed from the previous cohort(s).
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04731298
Sponsor's protocol ID
NI-0501-12
Status last verified
Dec 2023
First submitted
13 Nov 2020
Last updated
28 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Emapalumab in people with Graft Failure, run by Swedish Orphan Biovitrum at 5 sites in 3 countries.

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 12 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, Israel, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 28 Dec 2023). 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?

CXCL9 in Serum (time frame: From start of treatment to EoS Visit, up to 34 weeks). The study lists 3 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 NCT04731298.

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 28 Dec 2023.

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