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NNC0215-0384 · 2 trials · 2 indications
| 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 ...
NNC0215-0384 is an investigational small molecule being developed for inflammation, specifically for rheumatoid arthritis. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
NNC0215-0384 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO.
NNC0215-0384 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and the drug remains investigational, meaning it has not been approved for any use.
NNC0215-0384 has been studied in two completed Phase 1 trials: NCT01611688, a first human dose trial in subjects with rheumatoid arthritis, and NCT01955603, a safety, tolerability, pharmacokinetics and pharmacodynamics trial in subjects with moderate to severe rheumatoid arthritis.
NNC0215-0384 is the sole name provided for this investigational drug. No alternative names have been associated with it in the clinical trial records.