Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Official title

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Overview

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.

Interventions

• Drug Mirikizumab
  Administered IV
• Drug Mirikizumab
  Administered SC
• Drug Tirzepatide
  Administered SC
• Drug Placebo
  Administered SC

Primary outcome measures

• Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction [Time frame: Week 52]

Secondary outcome measures (6)

• Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission [Time frame: Week 24, 52]
• Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI [Time frame: Week 52]
• Percentage of Participants Who Achieved Maintenance of Endoscopic Remission [Time frame: Week 52]
• Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline [Time frame: Week 52]
• Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time frame: Baseline, Week 52]
• Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight [Time frame: Week 52]

Eligibility criteria

Inclusion criteria

• Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
• Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:

• hypertension
• Type 2 diabetes mellitus (T2DM)
• dyslipidemia
• obstructive sleep apnea, or
• cardiovascular disease.
• Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
• Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
• Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
• Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Exclusion criteria

• Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
• Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
• Currently have or are suspected to have an abscess.
• Have a stoma, ileoanal pouch, or ostomy.
• Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
• Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
• Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
• Have had more than 5% body weight change in the past 3 months
• Have a current or recent acute, active infection.

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

Double blind

Primary purpose

Treatment

Study locations

United States · 35 centers

• Digestive Health Specialists — Dothan
• Smart Cures Clinical Research — Anaheim
• Cedars-Sinai Medical Center — Beverly Hills
• United Medical Doctors - Los Alamitos — Los Alamitos
• California Medical Research Associates — Northridge
• Research Associates of South Florida - Miami - Southwest 8th Street — Miami
• Gastro Health Research - Miami — Miami
• Orlando Health — Orlando
• … and 27 more centers

Mexico · 16 centers

Center list to be confirmed — check the primary protocol.

Brazil · 15 centers

• NewData Clinical Research - Aracaju — Aracaju
• L2IP - Instituto de Pesquisas Clínicas — Brasília
• Loema Instituto de Pesquisa Clinica — Campinas
• Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul
• Centro Digestivo de Curitiba — Curitiba
• Galileo Medical Research — Juiz de Fora
• Hospital de Clinicas de Porto Alegre — Porto Alegre
• Hospital de Clínicas de Ribeirão Preto — Ribeirão Preto
• … and 7 more centers

Poland · 12 centers

Center list to be confirmed — check the primary protocol.

France · 11 centers

Center list to be confirmed — check the primary protocol.

Spain · 10 centers

Center list to be confirmed — check the primary protocol.

Italy · 9 centers

Center list to be confirmed — check the primary protocol.

Turkey (Türkiye) · 9 centers

Center list to be confirmed — check the primary protocol.

Israel · 8 centers

Center list to be confirmed — check the primary protocol.

Canada · 7 centers

• Gastroenterology and internal medicine research institute — Edmonton
• London Health Sciences Centre — London
• London Digestive Disease Institute — London
• Clinique IMD — Montreal
• The Ottawa Hospital - General Campus — Ottawa
• Vancouver General Hospital — Vancouver
• (G.I.R.I.) GI Research Institute Foundation — Vancouver

Belgium · 6 centers

• AZORG Campus Aalst-Moorselbaan — Aalst
• Université Libre de Bruxelles - Hôpital Erasme — Brussels
• AZ Groeninge Campus Kennedylaan — Kortrijk
• UZ Leuven — Leuven
• Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège
• Clinical Chc Montlégia — Liège

Czechia · 6 centers

• SurGal Clinic — Brno
• Gastroenterologie — Hradec Králové
• EndoArt — Ostrava
• ResTrial GastroEndo s.r.o — Prague
• ISCARE klinické centrum — Prague
• Masarykova Nemocnice V Usti Nad Labem — Ústí nad Labem

Denmark · 6 centers

• Aarhus Universitetshospital, Skejby — Aarhus
• Rigshospitalet — Copenhagen
• Herlev and Gentofte Hospital — Copenhagen
• Aalborg Universitetshospital, Syd — Gistrup
• Odense Universitetshospital — Odense
• … and 1 more center

Germany · 6 centers

Center list to be confirmed — check the primary protocol.

Romania · 6 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 5 centers

Center list to be confirmed — check the primary protocol.

Greece · 4 centers

Center list to be confirmed — check the primary protocol.

Hungary · 4 centers

Center list to be confirmed — check the primary protocol.

Slovakia · 4 centers

Center list to be confirmed — check the primary protocol.

Austria · 3 centers

• Medizinische Universität Graz — Graz
• Medizinische Universitaet Innsbruck — Innsbruck
• Medizinische Universität Wien — Vienna

Bulgaria · 3 centers

• University Hospital "St. Ivan Rilski" — Gorna Oryahovitsa
• Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD — Sofia
• University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD — Sofia

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06937099 · 27281 · 2024-520210-21-00 · I6T-MC-AMCE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗