A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Active Granulomatosis With Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological, Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria
• Positive test for ANCA-autoantibodies
• GPA and MPA participants with severe active disease
Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Evanston
Oregon
Oregon Health Sciences University
RECRUITING
Portland
Utah
LDS Hospital
RECRUITING
Salt Lake City
Other Locations
Israel
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Ramat Gan
Japan
Novartis Investigative Site
RECRUITING
Chiba
Novartis Investigative Site
RECRUITING
Kanazawa
Novartis Investigative Site
RECRUITING
Kobe
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sendai
Novartis Investigative Site
RECRUITING
Suita
Saudi Arabia
Novartis Investigative Site
RECRUITING
Riyadh
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Switzerland
Novartis Investigative Site
RECRUITING
Basel
Novartis Investigative Site
RECRUITING
Bern
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: 2025-03-13
Estimated Completion Date: 2030-05-24
Participants
Target number of participants: 126
Treatments
Experimental: Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol
Active_comparator: Active comparator
Comparator and concomitant glucocorticoids as per protocol
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals