A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis

Status: Recruiting
Location: See all (64) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy.

• Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit.

• Severe, progressive systemic sclerosis disease defined by at least one of the following:

‣ Progressive systemic sclerosis-associated interstitial lung disease

⁃ Severe, progressive systemic sclerosis skin disease

⁃ Clinically significant systemic sclerosis-associated cardiac involvement at Screening

Locations
United States
California
UCSF
RECRUITING
San Francisco
UCSF
RECRUITING
San Francisco
Sutter Health Network
RECRUITING
San Pablo
Iowa
University Of Iowa
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Boston Medical Center
RECRUITING
Boston
Michigan
Michigan Med University of Michigan
RECRUITING
Ann Arbor
Ohio
James Cancer Hospital
RECRUITING
Columbus
Oregon
Oregon Health Sciences University
RECRUITING
Portland
South Dakota
Avera Cancer
RECRUITING
Sioux Falls
Utah
LDS Hospital
RECRUITING
Salt Lake City
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Darlinghurst
Austria
Novartis Investigative Site
RECRUITING
Graz
Denmark
Novartis Investigative Site
RECRUITING
Aarhus N
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Dijon
Novartis Investigative Site
RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Rennes
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Halle
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
RECRUITING
Leipzig
Novartis Investigative Site
RECRUITING
Mainz
Novartis Investigative Site
RECRUITING
Nuremberg
Novartis Investigative Site
RECRUITING
Ulm
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Israel
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Ramat Gan
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Ancona
Novartis Investigative Site
RECRUITING
Bergamo
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Genova
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Pavia
Novartis Investigative Site
RECRUITING
Perugia
Novartis Investigative Site
RECRUITING
Pisa
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Udine
Japan
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
Netherlands
Novartis Investigative Site
RECRUITING
Utrecht
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Pamplona
Novartis Investigative Site
RECRUITING
Salamanca
Novartis Investigative Site
RECRUITING
Santander
Novartis Investigative Site
RECRUITING
Santiago Compostela
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Geneva
Novartis Investigative Site
RECRUITING
Lausanne
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
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: 2024-10-29
Estimated Completion Date: 2032-08-30
Participants
Target number of participants: 86
Treatments
Experimental: rapcabtagene autoleucel arm
rapcabtagene autoleucel
Active_comparator: rituximab arm
rituximab
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov