Recruiting
Phase 2

Eltrekibart & Mirikizumab

Sponsor:

Eli Lilly and Company

Code:

NCT06598943

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Eltrekibart

Mirikizumab

Placebo

Study Details

Brief summary:

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).

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic

Study ID

NCT06598943

Start date

Oct 10, 2024

Status verified date

Jul, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

143 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eltrekibart + Placebo

Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.

experimental: Mirikizumab + Placebo

Participants will receive mirikizumab and placebo or mirikizumab.

experimental: Eltrekibart + Mirikizumab

Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.

experimental: Placebo

Participants will receive placebo or mirikizumab.

Interventions

Eltrekibart

Administered

Mirikizumab

Administered

Placebo

Administered

Primary outcome measure

  • Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Applied Research Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

501-954-7822

Principal Investigator:

Angelo Coppola

Erick Alayo Medical Corp/Gastro SB Clinic

Recruiting

Chula Vista, California, United States, 91910

Contacts

619-513-3372

Principal Investigator:

Erick Alayo

Southern California GI and Liver Centers (SCLC)

Recruiting

Coronado, California, United States, 92118

Contacts

(619) 522-0330

Principal Investigator:

Tarek Hassanein

Valley View Research

Recruiting

Garden Grove, California, United States, 92845

Contacts

855-229-1665

Principal Investigator:

Michael Kurtz

Om Research, LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

(661) 388-2239

Principal Investigator:

Jatinder Pruthi

United Medical Doctors

Recruiting

Los Alamitos, California, United States, 90720-3433

Contacts

5624304449

Principal Investigator:

Seyedehsan Navabi

Clinnova Research

Recruiting

Orange, California, United States, 92868-4402

Contacts

(949) 889-0249

Principal Investigator:

Amit Bhanvadia

Prospective Research Innovations

Recruiting

Rancho Cucamonga, California, United States, 91730-4850

Contacts

(707) 940-7767

Principal Investigator:

Tarek Ezzeddine

Clinical Trials Management Services, LLC

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

1-805-906-7800

Principal Investigator:

MAHENDRA PATEL

Om Research LLC

Recruiting

Victorville, California, United States, 92395

Contacts

661-388-2239

Principal Investigator:

Thomas Nguyen

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907-6262

Contacts

(719) 362-2281

Principal Investigator:

Bhaktasharan Patel

Medical Research Center of Connecticut, LLC

Recruiting

Hamden, Connecticut, United States, 06518-3602

Contacts

(203) 281-5161

Principal Investigator:

Paul Feuerstadt

Well Pharma Medical Research Corp.

Recruiting

Miami, Florida, United States, 33173

Contacts

305-665-4818

Principal Investigator:

Eddie Armas

Orlando Health Digestive Health Institute

Recruiting

Orlando, Florida, United States, 32803-1248

Contacts

(216) 502-0981

Principal Investigator:

Udayakumar Navaneethan

Nodal Medical Center

Recruiting

Tampa, Florida, United States, 33607

Contacts

(813) 374-0568

Principal Investigator:

Leopoldo Grauer

Research Bay,Inc.

Recruiting

Tampa, Florida, United States, 33607

Contacts

(813) 304-1265

Principal Investigator:

Mina Elnemr

GCP Clinical Research, LLC

Recruiting

Tampa, Florida, United States, 33609

Contacts

813-240-9734

Principal Investigator:

Alan Weintraub

International Center for Research LLC

Recruiting

Tampa, Florida, United States, 33614

Contacts

(813) 930-8816

Principal Investigator:

Angel Rosario

Avicenna Clinical Research - SW Gastroenterology

Recruiting

Oak Lawn, Illinois, United States, 60453-3754

Contacts

(708) 499-5678

Principal Investigator:

Charles Berkelhammer

Gastroenterology Associates of Western Michigan, P.L.C.

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

(616) 328-5344

Principal Investigator:

Allan Coates

Ellipsis Research Group

Recruiting

Brooklyn, New York, United States, 11215

Contacts

(347) 422-0317

Principal Investigator:

Jorge Serje

Smart Medical Research - Jackson Heights

Recruiting

Jackson Heights, New York, United States, 11372

Contacts

(718) 305-1900

Principal Investigator:

Gulam Khan

Pioneer Clinical Research NY

Recruiting

New York, New York, United States, 10012-3645

Contacts

(917) 977-0900

Principal Investigator:

Murray Orbuch

Digestive Disease Medicine of Central New York

Recruiting

Utica, New York, United States, 13502

Contacts

(315) 624-7035

Principal Investigator:

Harvey Allen

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

(919) 445-3880

Principal Investigator:

Animesh Jain

GCGA Physicians, LLC dba / Gastro Health Research

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

513-872-4549

Principal Investigator:

Pradeep Bekal

NexGen Research

Recruiting

Lima, Ohio, United States, 45801

Contacts

419-516-0954 Ext 105

Principal Investigator:

Nonso Ezema

Inquest Clinical Research

Recruiting

Baytown, Texas, United States, 77521

Contacts

(281) 428-8203

Principal Investigator:

Haider Afzal

DHR Health Gastroenterology - Edinburg

Recruiting

Edinburg, Texas, United States, 78539

Contacts

956-362-2356

Principal Investigator:

Murthy Badiga

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

(713) 798-7616

Principal Investigator:

Jason Hou

Intergrity Research

Recruiting

Houston, Texas, United States, 77043

Contacts

(832) 860-0720

Principal Investigator:

Mouhamad Al-Sabbagh

Gastroenterology Research of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

(210) 615-3848

Principal Investigator:

Nicholas Martinez

Tyler Research Institute

Recruiting

Tyler, Texas, United States, 75701

Contacts

(903) 630-6211

Principal Investigator:

George Duvall

Care Access-Ogden

Recruiting

Ogden, Utah, United States, 84403

Contacts

(801) 614-0010

Principal Investigator:

Chad Gonzales

Advanced Research Institute - South Ogden

Recruiting

Ogden, Utah, United States, 84405

Contacts

(801) 409-2040

Principal Investigator:

John Lowe

London Health Sciences Centre

Recruiting

London, Canada, N6A 5W9

Contacts

519-685-8500 ext: 77809

Principal Investigator:

Terry Ponich

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • CXCR1/2 Ligand receptor antagonist
  • IL-23 p19 antibody
  • Gastrointestinal Diseases
  • Inflammatory Bowel Diseases
  • Digestive System Diseases
  • Colonic Diseases
  • Intestinal Diseases
  • Colitis
  • Colitis, Ulcerative
  • Anti-Inflammatory Agents
  • Mirikizumab
  • Eltrekibart
  • Adult
  • Moderate to Severe

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-30.