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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512986-15-00 | EU Trial (CTIS) Number |
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Terminated due to strategic business decision.
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| Name | Class |
|---|---|
| Kiniksa Pharmaceuticals, GmbH | INDUSTRY |
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Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiprubart 400mg SC q2wk | Experimental | Part A: Loading dose of abiprubart 800 mg subcutaneous (SC) followed by abiprubart 400 mg SC every 2 weeks (q2wk) through Week 22. Part B: Abiprubart 400 mg SC q2wk: abiprubart 400 mg SC q2wk up to and including Week 46. |
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| Abiprubart 400mg SC q4wk | Experimental | Part A: Loading dose of abiprubart 800 mg SC followed by abiprubart 400 mg SC q2wk through Week 22 which will alternately administer placebo or abiprubart to provide active drug every 4 weeks (q4wk) while maintaining treatment concealment. Part B: Abiprubart 400 mg SC q4wk: abiprubart 400 mg SC q2wk up to and including Week 46 which will alternately administer placebo or abiprubart to provide active drug q4wk while maintaining treatment concealment. |
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| Placebo | Placebo Comparator | Part A: A matched volume placebo loading dose followed by placebo SC injections q2wk through Week 22. Part B: Participants assigned to placebo in Part A will transition to active abiprubart treatment, according to randomized assignment, with either abiprubart 400 mg SC q2wk or abiprubart 400 mg SC q4wk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiprubart | Drug | humanized monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24 | Week 24 | |
| Proportion of STAR Responders (≥ 5 points) Over Time | Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medvin Clinical Research | Menifee | California | 92586 | United States | ||
| BioSolutions Clinical Research Center |
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| Placebo | Drug | sterile preservative-free solution |
|
| Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24 | Baseline, Week 24 |
| Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24 | Baseline, Week 24 |
| Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24 | Baseline, Week 24 |
| Change From Baseline in ESSPRI Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in Schirmer's Test at Week 24 | Baseline, Week 24 |
| Change From Baseline in Schirmer's Test Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24 | Baseline, Week 24 |
| Change From Baseline in clinESSDAI Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24 | Baseline, Week 24 |
| Change From Baseline in FACIT-Fatigue Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24 | Baseline, Week 24 |
| Change From Baseline in EQ-5D 5L Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56 |
| Poway |
| California |
| 92064 |
| United States |
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| International Medical Research | Daytona Beach | Florida | 32117 | United States |
| Omega Research Debary, LLC | DeBary | Florida | 32713 | United States |
| Greater Chicago Specialty Physicians/ Clinical Investigation Specialists | Schaumburg | Illinois | 60195 | United States |
| Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc. | Skokie | Illinois | 60076 | United States |
| Springfield Clinic Rheumatology | Springfield | Illinois | 62702 | United States |
| Accurate Clinical Research, Inc | Lake Charles | Louisiana | 70605 | United States |
| Accellacare (Salisbury) | Salisbury | North Carolina | 28144 | United States |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | United States |
| Arthritis and Rheumatology Research Institute, PLLC | Allen | Texas | 75013 | United States |
| Arthritis Care of Texas | Corpus Christi | Texas | 78415 | United States |
| Trinity Universal Research Associates, Inc. | Plano | Texas | 75024 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Arthritis & Osteoporosis Clinic | Waco | Texas | 76710 | United States |