A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Refractory Idiopathic Inflammatory Myopathies (IIM)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Men and women, aged \>18 and ≤65 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
• Participants who had inadequate response to prior therapy
• Diagnosed with active disease
• Participant must meet criteria for severe myositis
Locations
United States
Iowa
University Of Iowa
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Utah
LDS Hospital
RECRUITING
Salt Lake City
Other Locations
France
Novartis Investigative Site
RECRUITING
Brest
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Rennes
Germany
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
RECRUITING
Leipzig
Israel
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Ramat Gan
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Milan
Japan
Novartis Investigative Site
RECRUITING
Bunkyo-ku
Novartis Investigative Site
RECRUITING
Izumo
Novartis Investigative Site
RECRUITING
Kanazawa
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sendai
Novartis Investigative Site
RECRUITING
Suita
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Pamplona
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2030-07-17
Participants
Target number of participants: 123
Treatments
Experimental: Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel (YTB323)
Active_comparator: Comparator
Investigator choice of treatment as per protocol
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals