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RECRUITING
NCT06868290
PHASE2

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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)

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-03-13

Completion Date

2030-05-24

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

Rapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel

OTHER

Active Comparator

Active comparator option as per protocol

DRUG

Glucocorticoids

Concomitant glucocorticoids as per protocol

Locations (31)

University Of Colorado

Aurora, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Oregon Health Sciences University

Portland, Oregon, United States

Houston Methodist Hospital

Houston, Texas, United States

LDS Hospital

Salt Lake City, Utah, United States

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Novartis Investigative Site

Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Riyadh, Saudi Arabia

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Basel, Switzerland

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Cambridge, United Kingdom

Novartis Investigative Site

London, United Kingdom