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Secukinumab Open Label Roll-over Extension Protocol
NCT04638647 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04638647
The ClinicalTrials.gov registry entry for NCT04638647 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04638647 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04638647?
The interventions under investigation include: Secukinumab s.c. injection (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04638647?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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