Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Secukinmab · 1 trial · 1 indication
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).
| Arm | Type | Description |
|---|---|---|
| Secukinumab 25mg | EXPERIMENTAL | Secukinumab 25mg s.c. q4wk |
| Secukinumab 75mg | EXPERIMENTAL | Secukinumab 75mg s.c. q4wk |
| Secukinumab 150mg | EXPERIMENTAL | Secukinumab 150mg s. c. q4wk |
| Secukinumab 300mg | EXPERIMENTAL | Secukinumab 300mg s.c. q4wk |
| Secukinumab Placebo | PLACEBO_COMPARATOR | Secukinumab Placebo s.c. q4wk |
| Name | Type | Description |
|---|---|---|
| Secukinmab | DRUG | Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. |
| Placebo | DRUG | Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. |
Inclusion Criteria: * Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (\> or =7.5 mg/week - \< or = 25 mg/week) for at least 4 weeks * At Baseline: Disease activity ...
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Secukinmab is an investigational small molecule being studied for the treatment of Rheumatoid Arthritis. It is being evaluated in patients with Rheumatoid Arthritis who are also taking Methotrexate. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Secukinmab is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of Secukinmab in patients with Rheumatoid Arthritis.
Secukinmab is currently in Phase 2 clinical development for Rheumatoid Arthritis. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 2 trial has been completed, and the drug remains under evaluation for this indication.
Secukinmab has one completed Phase 2 clinical trial registered as NCT00928512. This trial, titled "Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)," enrolled 237 participants across multiple countries including the United States, Belgium, Czechia, Germany, Hungary, Japan, Poland, Russia, Slovakia, South Korea, and Taiwan.
Yes, Secukinmab is also known as AIN457. The clinical trial NCT00928512, which studies Secukinmab in Rheumatoid Arthritis, uses the name AIN457 in its official title. Both names refer to the same investigational drug being developed by Novartis.
Yes, the Phase 2 clinical trial for Secukinmab in Rheumatoid Arthritis was a randomized, double-blind, placebo-controlled study. The trial enrolled 237 participants, all aged 18 years and older, and was conducted at multiple sites internationally. The study has been completed.