A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Part of paid clinical trials in Mesa, Arizona.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06470048
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Diffuse Cutaneous Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — DRUGIanalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
- Ianalumab — DRUGsubcutaneous (s.c.) injection as defined in the protocol
Study Details
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Key Dates
- Start date
- Oct 9, 2024
- Status verified
- Jun 2026
- Primary completion
- Jul 30, 2027
- Completion
- Jul 31, 2034
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VAY736 (Ianalumab)Treatment Period 1: Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
- Placebo Comparator: PlaceboTreatment Period 1: Placebo to Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
Primary Outcome Measure
3/5 rCRISS25 response [ Time Frame: Week 52 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Arthritis and Rheumatology Research PLLC | Mesa | Arizona | 85202 | Nehad Soloman (PRINCIPAL_INVESTIGATOR) |
| UCLA | Los Angeles | California | 90095 | Suzanne Kafaja (PRINCIPAL_INVESTIGATOR) |
| Hoag Hospital | Newport Beach | California | 92663 | Christine Thai (PRINCIPAL_INVESTIGATOR) |
| Clinical Res Of W Florida | Clearwater | Florida | 33765 | Rodney Daniel (PRINCIPAL_INVESTIGATOR) |
| GNP Research | Cooper City | Florida | 33024 | Mark Jaffe (PRINCIPAL_INVESTIGATOR) |
| IRIS Research and Development | Plantation | Florida | 33324 | Guillermo Valenzuela (PRINCIPAL_INVESTIGATOR) |
| Sarasota Arthritis Res Ctr | Sarasota | Florida | 34239 | Jaishree Manohar (PRINCIPAL_INVESTIGATOR) |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | Michael Macklin (PRINCIPAL_INVESTIGATOR) |
| UMC New Orleans | New Orleans | Louisiana | 70112 | Sean Barry Stephen Lindsey (PRINCIPAL_INVESTIGATOR) |
| Uni Of Michigan Health System | Ann Arbor | Michigan | 48109 | Carleigh Zahn (PRINCIPAL_INVESTIGATOR) |
| Wayne State University | Detroit | Michigan | 48201 | Biljana Basic-Panic Ilyes Benchaala (PRINCIPAL_INVESTIGATOR) |
| Clinical Research Inst of MI | Saint Clair Shores | Michigan | 48081 | Andrew Sulich (PRINCIPAL_INVESTIGATOR) |
| Hospital for Special Surgery | New York | New York | 10021 | Kimberly Showalter Lakin (PRINCIPAL_INVESTIGATOR) |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | Jacob A Aelion (PRINCIPAL_INVESTIGATOR) |
| Arthritis and Rheumatology Ins | Allen | Texas | 75013 | Samina Shehzad Megha Patel Banker. (PRINCIPAL_INVESTIGATOR) |
| Novel Research LLC | Bellaire | Texas | 77401 | Hassan Khan Wajeeha Yousaf (PRINCIPAL_INVESTIGATOR) |
| Prolato Clinical Research Center | Houston | Texas | 77054 | Michelle Eisenberg (PRINCIPAL_INVESTIGATOR) |
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