Primary Sjögren's SyndromePhase 2NCT01552681

Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

A Phase 2 study testing Baminercept in people with Primary Sjögren's Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Terminated

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

Official record

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Trial summary

The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome. The study will also determine if the study agent can be safely given to patients with Sjögren's syndrome; examine how it affects symptoms of the disease; and attempt to… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Sjögren's Syndrome
What is being tested?: Baminercept
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 9 sitesUnited States
Study dates: Jul 2012to Jun 2015
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has provided written informed consent;
Between the ages of 18-75 years (inclusive);
Body weight ≥ 40 kg;
Meets the revised European criteria proposed by the American-European Consensus Group for primary Sjögren's Syndrome at screening. These criteria include 3 of the following 4 items:
ocular symptoms;
oral symptoms;

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Schirmer's I test showing less than 6 mm of wetting per five minutes in at least one eye, or filamentary keratitis on slit lamp examination, or positive lissamine green staining; or
diminished salivary production (unstimulated whole salivary flow rate ≤ 1.5 mL/15 min); PLUS, either:
a positive test for serum SS-A and/or SS-B antibodies, or
focal lymphocytic sialadenitis, with a focus score ≥ 1.0 per 4 millimeters ^2(mm^2) on minor salivary biopsy.
Stimulated salivary flow of ≥ 0.1 mL/minute (min) (at screening);
Has one or more of the following systemic manifestations of Sjögren's Syndrome that are not life-threatening:
fatigue (as measured by > 50 mm on a 100 mm VAS);
joint pain (as measured by > 50 mm on a 100 mm VAS);
peripheral neuropathy (documented by nerve conduction velocity study);
interstitial lung disease (documented by radiography and/or altered pulmonary function tests;
leukocytoclastic vasculitis;
renal tubular acidosis;
interstitial nephritis;
severe parotid swelling;
other extraglandular manifestations causing organ system dysfunction.
If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 10 mg/day and stable for at least 4 weeks prior to Screening;
If taking hydroxychloroquine, the dose must be stable for at least 12 weeks prior to Screening;
If taking a cholinergic stimulant (e.g. pilocarpine, cevimeline), the dose must be stable for at least 4 weeks prior to Screening;
Subjects must agree not to become pregnant or to impregnate a female. Because of the risk involved, participants and their partners (if of reproductive potential) must use two methods of birth control. They must continue to use both methods until 6 months after stopping study drug. Two of the birth control methods listed below may be chosen:
Hormonal contraception;
Male or female condoms with or without spermicide;
Diaphragm or cervical cap with a spermicide;
Intrauterine device (IUD).

Who cannot join

Has an active infection excluding superficial cutaneous fungal or viral infections;
Has a chronic or persistent infection that might be worsened by immunosuppressive treatment (e.g., human immunodeficiency virus [HIV], hepatitis B, hepatitis C, or tuberculosis);
History of TB or positive intradermal skin test for purified protein derivative (PPD); positive Mantoux test defined as 10 mm of induration (size of raised bump, not redness), or equivalent positive TB test result, as per country clinical standards, during the screening period. Subjects whose PPD induration is ≥ 5 mm but < 10 mm are eligible for the study if they had a negative chest x-ray during the screening period. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation. PPD should not be administered within 6 weeks of a live-virus vaccine;
History of recurrent significant infections or occurrence of a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within twelve weeks prior to Day 0;
Receipt of live vaccine within six weeks prior to Day 0;
History or presence of primary or secondary immunodeficiency;

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History of any life-threatening allergic reactions;
Is a pregnant or nursing female;
Ongoing anticoagulant therapy, which is a contraindication for labial salivary biopsy or tonsil biopsy;
Concurrent use of anticholinergic agents, such as tricyclic antidepressants, antihistamines, phenothiazines, antiparkinsonian drugs, anti-asthmatic medications, or gastrointestinal (GI) medications that cause xerostomia in more than 10% of patients;
Treatment with any of the following within the defined period prior to Screening:
2 years for rituximab;
24 weeks for cyclophosphamide;
8 weeks for azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil;
4 weeks for intravenous immunoglobulin;
4 weeks for etanercept;
8 weeks for adalimumab;
12 weeks for infliximab.
Prednisone (or equivalent corticosteroid) > 10 mg/day;
A definite diagnosis of RA, SLE, systemic sclerosis, or dermatomyositis;
A history of alcohol or substance abuse within 12 months of the screening visit;
A history of head and neck radiation therapy, sarcoidosis, or graft-versus-host disease;
A history of malignancy, except for a resected basal or major squamous cell carcinoma, cervical dysplasia, or in situ cervical cancer Grade I, within the last five years;
Severe pulmonary disease as manifested by one of the following at Screening:
Resting oxygen saturation < 92%;
Force vital capacity (FVC) < 50% predicted;
Diffusion lung capacity for carbon monoxide (DLCO) < 50%;
Abnormal laboratory results for the following parameters at the screening visit:
Absolute neutrophil count (ANC): < 1,500/mm^3;
Platelets: < 100,000/mm^3;
Hemoglobin: < 9 grams (g)/deciliter (dL);
Serum creatinine: ≥ 2.0 mg/dL;
AST: > 1.5x upper limit of normal, or
ALT: > 1.5x upper limit of normal.
A psychiatric disorder rendering the subject incapable of providing informed consent;
Plans for foreign travel to countries other than Canada or Western Europe within the treatment period;
Inability or unwillingness to follow the protocol;
Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial;
Rochester substudy subjects who meet the following criteria are disqualified from enrolling in the tonsil biopsy substudy if they:
Have any side effects to local anesthetics (e.g., lidocaine);
Have any side effects to silver nitrate;
Do not have tonsils;
Are not able to go 48 hours without any NSAIDS;
Are not able to go 2 weeks without acetylsalicylic acid (aspirin).

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Johns Hopkins Medical Institute
Baltimore, Maryland, 21224
University of Chicago
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Stanford University
Palo Alto, California, 94304
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)

Read the detailed description

Sjögren's syndrome is an autoimmune disorder in which a person's own immune cells attack the body's tear and salivary glands. This disease is the second most common autoimmune disorder, affects close to four million people in the U.S., and has no known cause. About one-third of patients with Sjögren's syndrome have enlarged parotid glands (the largest salivary glands, the glands that make saliva); inflammation of organs such as the lungs and joints may also occur. There is no known effective treatment other than measures that can relieve symptoms. One of the most bothersome symptoms is dryness of the eyes and mouth. Eye drops and saliva stimulants (which help make more saliva) are common treatments. When other organs are affected, symptoms are treated with corticosteroids (prednisone), non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen and naproxen), hydroxychloroquine (Plaquenil®) or other medications that suppress the immune system. These drugs may curb or kill cells of the immune system, but they are not always helpful, do not cure Sjögren's syndrome, and can have many side effects.

Conditions: Primary Sjögren's Syndrome
Being tested: Baminercept, Placebo
Keywords: baminercept treatment

What participants receive

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

BaminerceptBiological
Also called lymphotoxin-beta receptor-immunoglobulin fusion protein
Subjects randomized to baminercept (2:1) will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.
PlaceboOther
Also called baminercept placebo
Subjects randomized to placebo will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.

Study groups in NCT01552681
Study group	Role	What they receive
Baminercept	Experimental	Subcutaneous injections of 100 mg every week for 24 weeks Receives: Biological: Baminercept
Placebo	Placebo comparator	Subcutaneous injections of matched placebo every week for 24 weeks Receives: Other: Placebo

What is being measured

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

Change From Screening in Stimulated Whole Salivary Flow at Week 24
After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Measured: Screening to Week 24

Secondary outcomes (21)

Change From Screening in Stimulated Whole Salivary Flow at Week 48
After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Measured: Screening to Week 48
Change From Screening in Unstimulated Whole Salivary Flow at Week 24
The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Measured: Screening to Week 24
Change From Screening in Unstimulated Whole Salivary Flow at Week 48
The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Measured: Screening to Week 48
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Baseline to Week 24
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Measured: Week 24
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Measured: Week 48
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24
On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 24
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48
On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 48
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 24
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 48
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24
A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 24
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48
A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 48
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24
A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Measured: Week 24
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48
A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Measured: Week 48
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24
Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 24
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48
Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.
Measured: Week 48
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24
The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Measured: Week 24
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48
The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Measured: Week 48
Percent of Participants With Adverse Events of Grade 3 or Higher
Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Measured: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Percent of Participants With Grade 3 or Higher Infection Adverse Event
Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Measured: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection
Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Measured: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.

Timeline

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

Jul 2012Jun 2015

First posted13 Mar 2012 (estimated)
Study startJul 2012
Primary completionJan 2015
Study completionJun 2015

Why it stopped: Expired experimental study agent, no additional supply available.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Sjögren's SyndromeStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01552681
Sponsor's protocol ID: DAIT ASJ02
Status last verified: Dec 2018
First submitted: 9 Mar 2012
Last updated: 14 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.

Publications

St Clair EW, Baer AN, Wei C, Noaiseh G, Parke A, Coca A, Utset TO, Genovese MC, Wallace DJ, McNamara J, Boyle K, Keyes-Elstein L, Browning JL, Franchimont N, Smith K, Guthridge JM, Sanz I, James JA; Autoimmunity Centers of Excellence. Clinical Efficacy and Safety of Baminercept, a Lymphotoxin beta Receptor Fusion Protein, in Primary Sjogren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2018 Sep;70(9):1470-1480. doi: 10.1002/art.40513. Epub 2018 Jul 18.
PubMed 29604186

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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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)
ClinicalTrials.gov ID: NCT01552681
Acronym / sponsor ID: DAIT ASJ02
Conditions: Primary Sjögren's Syndrome
Keywords: baminercept treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Expired experimental study agent, no additional supply available.
Enrolment: 52 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Autoimmunity Centers of Excellence, Biogen
Study start: Jul 2012
Primary completion: Jan 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Mar 2012 (estimated)
Results: Posted 23 Mar 2016

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: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Baminercept	Experimental	Biological: BaminerceptSubcutaneous injections of 100 mg every week for 24 weeks
Placebo	Placebo comparator	Other: PlaceboSubcutaneous injections of matched placebo every week for 24 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

Has provided written informed consent;
Between the ages of 18-75 years (inclusive);
Body weight ≥ 40 kg;
Meets the revised European criteria proposed by the American-European Consensus Group for primary Sjögren's Syndrome at screening. These criteria include 3 of the following 4 items:
Stimulated salivary flow of ≥ 0.1 mL/minute (min) (at screening);

Key exclusion criteria (44 listed)

Has an active infection excluding superficial cutaneous fungal or viral infections;
Has a chronic or persistent infection that might be worsened by immunosuppressive treatment (e.g., human immunodeficiency virus [HIV], hepatitis B, hepatitis C, or tuberculosis);
History of TB or positive intradermal skin test for purified protein derivative (PPD); positive Mantoux test defined as 10 mm of induration (size of raised bump, not redness), or equivalent positive TB test result, as per country clinical standards, during the screening period. Subjects whose PPD induration is ≥ 5 mm but < 10 mm are eligible for the study if they had a negative chest x-ray during the screening period. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation. PPD should not be administered within 6 weeks of a live-virus vaccine;
History of recurrent significant infections or occurrence of a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within twelve weeks prior to Day 0;
Receipt of live vaccine within six weeks prior to Day 0;

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
BaminerceptAlso: lymphotoxin-beta receptor-immunoglobulin fusion proteinSubjects randomized to baminercept (2:1) will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.	Biological	Baminercept
PlaceboAlso: baminercept placeboSubjects randomized to placebo will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.	Other	Placebo

Primary outcome

Change From Screening in Stimulated Whole Salivary Flow at Week 24
Time frame: Screening to Week 24
After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.

21 secondary outcomes

Change From Screening in Stimulated Whole Salivary Flow at Week 48
Time frame: Screening to Week 48
Change From Screening in Unstimulated Whole Salivary Flow at Week 24
Time frame: Screening to Week 24
Change From Screening in Unstimulated Whole Salivary Flow at Week 48
Time frame: Screening to Week 48
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Time frame: Baseline to Week 24
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Time frame: Week 24
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Time frame: Week 48
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24
Time frame: Week 24
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48
Time frame: Week 48
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Time frame: Week 24
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Time frame: Week 48
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24
Time frame: Week 24
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48
Time frame: Week 48
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24
Time frame: Week 24
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48
Time frame: Week 48
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24
Time frame: Week 24
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48
Time frame: Week 48
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24
Time frame: Week 24
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48
Time frame: Week 48
Percent of Participants With Adverse Events of Grade 3 or Higher
Time frame: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Percent of Participants With Grade 3 or Higher Infection Adverse Event
Time frame: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection
Time frame: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.

Results and safety

Results posted to the registry on 23 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baminercept 100 mg	33	28
Placebo	19	18

Primary outcome: Change From Screening in Stimulated Whole Salivary Flow at Week 24

Time frame: Screening to Week 24. Mean (Standard Deviation). Unit: mL/min

Measure	Baminercept 100 mg n = 32	Placebo n = 19
Value	0.0 (0.3)	0.1 (0.2)

Baminercept 100 mg vs Placebo: p = 0.33, ANCOVA

Population analysed: The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baminercept 100 mg	5 of 33 (15.2%)	33 of 33 (100%)	Not reported
Placebo	1 of 19 (5.3%)	18 of 19 (94.7%)	Not reported

Limitations and caveats (from the sponsor): Randomization was prematurely stopped in July 2014 due to study product expiration. 52 of the 72 planned subjects were randomized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29604186St Clair EW, Baer AN, Wei C, Noaiseh G, Parke A, Coca A, Utset TO, Genovese MC, Wallace DJ, McNamara J, Boyle K, Keyes-Elstein L, Browning JL, Franchimont N, Smith K, Guthridge JM, Sanz I, James JA; Autoimmunity Centers of Excellence. Clinical Efficacy and Safety of Baminercept, a Lymphotoxin beta Receptor Fusion Protein, in Primary Sjogren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2018 Sep;70(9):1470-1480. doi: 10.1002/art.40513. Epub 2018 Jul 18.
National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.

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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.

E. William St. Clair, MD study chair

Duke University

Judith A. James, MD study chair

Oklahoma Medical Research Foundation

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baminercept in people with Primary Sjögren's Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

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 29 inclusion and 44 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 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 23 Mar 2016). 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?

Change From Screening in Stimulated Whole Salivary Flow at Week 24 (time frame: Screening to Week 24). 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 NCT01552681, which also lists 1 linked publication.

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 14 Jan 2019.