A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Official title

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Overview

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Interventions

• Drug Guselkumab
  Guselkumab will be administered.
• Drug Risankizumab
  Risankizumab will be administered.

Primary outcome measures

• Number of Participants with Deep Remission at Week 52 [Time frame: At Week 52]

Secondary outcome measures (7)

• Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52 [Time frame: At Week 52]
• Number of Participants with Endoscopic Remission at Week 52 [Time frame: At Week 52]
• Number of Participants with Clinical Remission at Week 52 [Time frame: At Week 52]
• Number of Participants with Steroid-Free Clinical Remission at Week 52 [Time frame: At Week 52]
• Number of Participants with Abnormalities in Laboratory Parameters [Time frame: Up to Week 148]
• Number of Participants With Change From Baseline in Laboratory Abnormalities [Time frame: Up to week 148]
• Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention [Time frame: Up to Week 165]

Eligibility criteria

Inclusion criteria

• Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
• Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450
• Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:

• a minimum score of 1 for the component of "size of ulcers" AND
• a minimum score of 1 for the component of "ulcerated surface"
• In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
• Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Exclusion criteria

• Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
• Currently has or is suspected to have an abscess
• Has an active fistula during screening or at Week 0 with an anticipated need for surgery
• Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
• Currently has a malignancy or has a history of malignancy within 5 years before screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 31 centers

• Digestive Health Specialists of the Southeast — Dothan
• East View Medical Research — Mobile
• Clinnova Research — Anaheim
• United Gastroenterologists — Los Alamitos
• TLC Clinical Research Inc — Los Angeles
• Hoag Memorial Hospital — Newport Beach
• Medical Associates Research Group, Inc. — San Diego
• Peak Gastroenterology Associates — Colorado Springs
• … and 23 more centers

France · 11 centers

• CHU Amiens Picardie — Amiens
• Clermont Ferrand University Hospital — Clermont-Ferrand
• Institut Prive MICI Clinique des Cedres — Échirolles
• Aphm - Hopital Nord — Marseille
• CHU Nantes - Hotel Dieu — Nantes
• Clinique Ambroise Pare — Neuilly-sur-Seine
• CHU Nimes — Nîmes
• Aphp Hopital Saint Antoine — Paris
• … and 3 more centers

Germany · 9 centers

• GASTRO-Studien — Berlin
• … and 8 more centers

United Kingdom · 9 centers

Center list to be confirmed — check the primary protocol.

Denmark · 8 centers

• Aarhus University Hospital — Aarhus C
• Sydvestjysk Sygehus — Esbjerg
• NAU New Aalborg University Hospital — Gistrup
• Herlev Hospital — Herlev
• Nordsjaellands Hospital, Hillerod — Hilleroed
• Hvidovre Hospital — Hvidovre
• Bispebjerg Hospital — København NV
• Odense UH og Svendberg sygehus — Odense C

Hungary · 8 centers

Center list to be confirmed — check the primary protocol.

Poland · 8 centers

Center list to be confirmed — check the primary protocol.

Spain · 8 centers

Center list to be confirmed — check the primary protocol.

Canada · 7 centers

• GIRI Gastrointestinal Research Institute — Vancouver
• Charlton Digestive Disease Centre — Hamilton
• London Digestive Disease Institute — London
• Taunton Surgical Centre — Oshawa
• Toronto Immune and Digestive Health Institute Inc — Toronto
• Centre Hospitalier de l'Universite de Montreal — Montreal
• Clinique IMD — Montreal

Italy · 7 centers

Center list to be confirmed — check the primary protocol.

Slovakia · 7 centers

Center list to be confirmed — check the primary protocol.

Austria · 6 centers

• LKH-Univ. Klinikum Graz — Graz
• Medizinische Universitatsklinik Innsbruck — Innsbruck
• LKH - Universitätsklinikum der PMU Salzburg — Salzburg
• Krankenhaus der Barmherzigen Brüder — Vienna
• Klinikum Wels Grieskirchen — Wels
• Universitatsklinikum Wiener Neustadt — Wiener Neustadt

Belgium · 6 centers

• Cliniques Universitaires Saint Luc — Brussels
• Ziekenhuis Oost-Limburg — Genk
• Ghent University Hospital — Ghent
• Universitair Ziekenhuis Leuven — Leuven
• CHU de Liege — Liège
• Algemeen Ziekenhuis Delta — Roeselare

Czechia · 6 centers

• Vojenska nemocnice Brno — Brno
• Gastroenterologie, s.r.o., Hradec Kralove — Hradec Kralova
• Hepato-gastroenterologie HK, s.r.o. — Hradec Králové
• Fakultni Nemocnice Ostrava — Ostrava-Poruba
• Fakultni nemocnice Kralovske Vinohrady — Prague
• Fakultni Thomayerova nemocnice — Prague

Sweden · 6 centers

Center list to be confirmed — check the primary protocol.

China · 4 centers

• Changzhou No 2 Peoples Hospital — Changzhou
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The Sixth Affiliated Hospital Sun Yat sen University — Guangzhou
• Zhongda Hospital Southeast University — Nanjing

Netherlands · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07499232 · CNTO1959CRD3009 · CNTO1959CRD3009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗