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NCT04638647 · ClinicalTrials.gov registry record · Phase 4
Secukinumab Open Label Roll-over Extension Protocol
A Phase 4 study of Autoimmunity, Inflammation, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT04638647: Recruiting Phase 4 study of Autoimmunity, Inflammation, sponsored by Novartis Pharmaceuticals.
NCT04638647 is a Phase 4 study of Autoimmunity, Inflammation that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 1,000 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638647, a Phase 4 study of Autoimmunity, Inflammation, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
Primary Outcome
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Conditions Studied
Interventions
- BIOLOGICAL Secukinumab s.c. injection
Study Locations (20)
California
- Providence Medical Foundation - Fullerton
- Purushotham Akther and Roshan Kotha MD Inc - La Mesa
- Precn Comprehensive Clnl Rsch Solns - San Leandro
- Orrin Troum MD and Medical Associates - Santa Monica
- Inland Rheumatology Clinical Trials INC - Upland
- Medvin Clinical Research - Van Nuys
- Center for Rheumatology Research - West Hills
Florida
- Rheumatology Associates of South Florida - Boca Raton
- Homestead Assoc In Research Inc - Homestead
- IRIS Research and Development - Plantation
- Conquest Research - Winter Park
- FL Medical Clinic Orlando Health - Zephyrhills
Colorado
- Denver Arthritis Clinic - Denver
Illinois
- Willow Rheumatology Wellness - Willowbrook
Indiana
- Dawes Fretzin Clinical Rea Group - Indianapolis
Maryland
- Klein and Associates - Hagerstown
Michigan
- Ahmed Arif Medical Research Center - Grand Blanc
Nebraska
- Physician Research Collaboration - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2030-04-04 |
| Phase | Phase 4 |
What NCT04638647 shows while recruiting
NCT04638647 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Autoimmunity, Inflammation appearing as the primary indexed condition, and to 1 intervention - of which Secukinumab s.c. injection is the first listed.
NCT04638647 names 20 study sites across 10 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04638647 about?
NCT04638647 is a clinical study titled "Secukinumab Open Label Roll-over Extension Protocol". The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
What is the current status of trial NCT04638647?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,000 participants. The study started on 2020-12-22. Estimated completion is 2030-04-04.
What conditions does trial NCT04638647 study?
This clinical trial studies the following conditions: Autoimmunity, Inflammation.
What interventions are being tested in trial NCT04638647?
The interventions under investigation include: Secukinumab s.c. injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT04638647?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04638647 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04638647's enrollment target sits among peer trials
1,000 66th of 2000 higher than 1,930 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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