Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01955603 | A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2013 | Oct 1, 2014 | Oct 15, 2014 | 4 | Germany, Hungary +2 |
| NCT01611688 | First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 36 | — | — | Jun 4, 2012 | Jun 17, 2013 | Feb 27, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Dose level 1 | EXPERIMENTAL | - |
| Dose level 2 | EXPERIMENTAL | - |
| Dose level 3 | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NNC0215-0384 | DRUG | A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe. |
| placebo | DRUG | Placebo administered corresponding to NNC0215-0384 treatment |
Inclusion Criteria: * Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive) * Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and ...