A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eltrekibart, Mirikizumab, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Ulcerative Colitis Chronic. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Canada, Colombia +16
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis
Overview
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
Detailed description
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
Interventions
- Drug Eltrekibart
Administered - Drug Mirikizumab
Administered - Drug Placebo
Administered
Primary outcome measures
- Percentage of Participants Achieving Clinical Remission [Time frame: Week 12]
Secondary outcome measures (8)
- Percentage of Participants Achieving Clinical Response [Time frame: Week 12]
- Percentage of Participants Achieving Endoscopic Improvement [Time frame: Week 12]
- Percentage of Participants Achieving Endoscopic Remission [Time frame: Week 12]
- Percentage of Participants Achieving Clinical Remission [Time frame: Week 52]
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement [Time frame: Week 12]
- Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [Time frame: Baseline, Week 12]
- Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart [Time frame: Week 12]
- PK: Ctrough ss of Mirikizumab [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- Have had an established diagnosis of UC of ≥3 months in duration before baseline.
- Have moderately to severely active UC as assessed by the UC disease activity score.
- Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
- Are on a stable dose of certain oral UC medications (including corticosteroids).
- Must meet contraception requirements.
Exclusion criteria
- Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
- Have experienced a thrombotic event within 24 weeks before baseline.
- Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
- Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
- Have a history of certain adenomas, dysplasia's, or malignancies.
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 · 46 centers
- AZ Gastro Care - Chandler — Chandler
- Applied Research Center of Arkansas — Little Rock
- Preferred Research Partners — Little Rock
- Erick Alayo Medical Corp/Gastro SB Clinic — Chula Vista
- Southern California GI and Liver Centers (SCLC) — Coronado
- Valley View Research — Garden Grove
- Om Research, LLC — Lancaster
- United Medical Doctors — Los Alamitos
- … and 38 more centers
Japan · 34 centers
Center list to be confirmed — check the primary protocol.
Italy · 19 centers
Center list to be confirmed — check the primary protocol.
Poland · 18 centers
Center list to be confirmed — check the primary protocol.
Germany · 13 centers
- Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum — Augsburg
- Charité Campus Virchow-Klinikum — Berlin
- … and 11 more centers
Spain · 9 centers
Center list to be confirmed — check the primary protocol.
Serbia · 8 centers
Center list to be confirmed — check the primary protocol.
Greece · 7 centers
Center list to be confirmed — check the primary protocol.
Hungary · 7 centers
Center list to be confirmed — check the primary protocol.
Romania · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- CIPREC — CABA
- Mautalen Salud e Investigacion-Centro de Osteopatías Médicas — Ciudad Autonoma de Buenos Air
- Clínica Privada Independencia — Munro
- CER Instituto Medico — Quilmes
- Hospital Provincial del Centenario — Rosario
- Centro Medico Privado de Reumatologia — SAN M. de Tucuman
Croatia · 6 centers
- General Hospital Dr Andjelko Visic Bjelovar — Bjelovar
- Poliklinika Borzan — Osijek
- Special Hospital Medico — Rijeka
- General Hospital Dr. J. Bencevic — Slavonski Brod
- Poliklinika Solmed — Zagreb
- University Hospital Center Zagreb — Zagreb
France · 6 centers
- Henri Mondor Hospital — Créteil
- CHU De Grenoble Hopital Albert Michallon — Grenoble
- Centre Hospitalier Departemental (CHD) Vendee — La Roche-sur-Yon
- CHU de Nice Hopital de L'Archet — Nice
- Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - — Pierre-Bénite
- Chu de Rouen Hopital Charles Nicolle — Rouen
Canada · 4 centers
- London Health Sciences Centre — London
- London Digestive Disease Institute — London
- CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal
- Montreal General Hospital — Montreal
Czechia · 4 centers
- SurGal clinic s.r.o. — Brno
- Vojenska nemocnice Brno p.o. — Brno
- Etická komise Nemocnice Slaný — Slaný
- Etická komise Krajské nemocnice T. Bati, a. s. — Zlín
Turkey (Türkiye) · 4 centers
Center list to be confirmed — check the primary protocol.
Colombia · 3 centers
- Hospital Universitario Mayor Méderi — Bogotá
- Comité de Ética en Investigación Biomédica IPS Centro Médico Julián Coronel — Cali
- Centro de Inmunología y Genética (CIGE) — Medellín
Belgium · 2 centers
- Chu Tivoli — La Louvière
- CHU UCL Namur site Godinne — Yvoir
Latvia · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
- Bispebjerg Hospital — København NV
Ireland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06598943 · 18751 · I7P-MC-DSAG