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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Remission
Time frame: Week 12
Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Clinical Response
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Improvement
Percentage of Participants Achieving Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
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
Change From Baseline to Week 12 in IBDQ Total Score
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart
PK: Ctrough ss of Eltrekibart
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AZ Gastro Care - Chandler
Chandler, Arizona, United States
NOT_YET_RECRUITINGApplied Research Center of Arkansas
Little Rock, Arkansas, United States
RECRUITINGPreferred Research Partners
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGErick Alayo Medical Corp/Gastro SB Clinic
Chula Vista, California, United States
RECRUITINGSouthern California GI and Liver Centers (SCLC)
Coronado, California, United States
RECRUITINGValley View Research
Garden Grove, California, United States
RECRUITINGOm Research, LLC
Lancaster, California, United States
RECRUITINGUnited Medical Doctors
Los Alamitos, California, United States
RECRUITINGClinnova Research
Orange, California, United States
RECRUITINGProspective Research Innovations
Rancho Cucamonga, California, United States
RECRUITING...and 197 more locations
Time frame: Week 12
PK: Ctrough ss of Mirikizumab
PK: Ctrough ss of Mirikizumab
Time frame: Week 12