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NCT04209205 · ClinicalTrials.gov registry record · Phase 3
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
NCT04209205 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 381 participants.
The verdict
NCT04209205, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
Study Summary
The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.
Interventions
- DRUG Placebo
- DRUG AIN457 6 mg/kg i.v.
- DRUG AIN457 3 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2020-01-29 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04209205
The ClinicalTrials.gov registry entry for NCT04209205 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04209205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04209205 about?
NCT04209205 is a clinical study titled "Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis". The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic art...
What is the current status of trial NCT04209205?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2020-01-29. Estimated completion is 2022-05-17.
What interventions are being tested in trial NCT04209205?
The interventions under investigation include: Placebo (DRUG), AIN457 6 mg/kg i.v. (DRUG), AIN457 3 mg/kg (DRUG).
Who is sponsoring clinical trial NCT04209205?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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