A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06598943
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Ulcerative Colitis
- Ulcerative Colitis Chronic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Eltrekibart — DRUGAdministered
- Mirikizumab — DRUGAdministered
- Placebo — DRUGAdministered
Study Details
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).
Key Dates
- Start date
- Oct 10, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Eltrekibart + PlaceboParticipants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
- Experimental: Mirikizumab + PlaceboParticipants will receive mirikizumab and placebo or mirikizumab.
- Experimental: Eltrekibart + MirikizumabParticipants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
- Experimental: PlaceboParticipants will receive placebo or mirikizumab.
Primary Outcome Measure
Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 12 ]
Central Contacts
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (46)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AZ Gastro Care - Chandler | Chandler | Arizona | 85225 | 480-716-5392 Jae Kim (PRINCIPAL_INVESTIGATOR) |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | 501-954-7822 Angelo Coppola (PRINCIPAL_INVESTIGATOR) |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | 501-553-9987 John Baber (PRINCIPAL_INVESTIGATOR) |
| Erick Alayo Medical Corp/Gastro SB Clinic | Chula Vista | California | 91910 | 619-513-3372 Erick Alayo (PRINCIPAL_INVESTIGATOR) |
| Southern California GI and Liver Centers (SCLC) | Coronado | California | 92118 | 619-522-0330 Tarek Hassanein (PRINCIPAL_INVESTIGATOR) |
| Valley View Research | Garden Grove | California | 92845 | 855-229-1665 Michael Kurtz (PRINCIPAL_INVESTIGATOR) |
| Om Research, LLC | Lancaster | California | 93534 | 661-388-2239 Jatinder Pruthi (PRINCIPAL_INVESTIGATOR) |
| United Medical Doctors | Los Alamitos | California | 90720-3433 | 562-430-4449 Seyedehsan Navabi (PRINCIPAL_INVESTIGATOR) |
| Clinnova Research | Orange | California | 92868-4402 | 949-889-0249 Amit Bhanvadia (PRINCIPAL_INVESTIGATOR) |
| Prospective Research Innovations | Rancho Cucamonga | California | 91730-4850 | 707-940-7767 Tarek Ezzeddine (PRINCIPAL_INVESTIGATOR) |
| Clinical Trials Management Services, LLC | Thousand Oaks | California | 91360 | 1-805-906-7800 MAHENDRA PATEL (PRINCIPAL_INVESTIGATOR) |
| Om Research LLC | Victorville | California | 92395 | 661-388-2239 Thomas Nguyen (PRINCIPAL_INVESTIGATOR) |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907-6262 | 719-362-2281 Bhaktasharan Patel (PRINCIPAL_INVESTIGATOR) |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518-3602 | 203-281-5161 Paul Feuerstadt (PRINCIPAL_INVESTIGATOR) |
| Novum Research, LLC | Clermont | Florida | 34711 | 352-558-8655 Edriss Estime (PRINCIPAL_INVESTIGATOR) |
| I.V.A.M. Clinical & Investigational Center, LLC | Doral | Florida | 33126 | 786-803-8002 Jorge M. Venereo (PRINCIPAL_INVESTIGATOR) |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | 941-727-7772 Manuel Rodriguez (PRINCIPAL_INVESTIGATOR) |
| Reserka | Miami | Florida | 33176 | 786-785-6223 Victor Pina (PRINCIPAL_INVESTIGATOR) |
| Well Pharma Medical Research Corp. | Miami | Florida | 33173 | 305-665-4818 Eddie Armas (PRINCIPAL_INVESTIGATOR) |
| Digestive Disease Consultants DDCJAX | Orange Park | Florida | 32073-4752 | 904-406-0633 Samir Habashi (PRINCIPAL_INVESTIGATOR) |
| AdventHealth Orlando | Orlando | Florida | 32803 | Jennifer Seminerio Diehl (PRINCIPAL_INVESTIGATOR) |
| Orlando Health Digestive Health Institute | Orlando | Florida | 32803-1248 | 216-502-0981 Udayakumar Navaneethan (PRINCIPAL_INVESTIGATOR) |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | 813-240-9734 Alan Weintraub (PRINCIPAL_INVESTIGATOR) |
| International Center for Research LLC | Tampa | Florida | 33614 | 813-930-8816 Angel Rosario (PRINCIPAL_INVESTIGATOR) |
| Nodal Medical Center | Tampa | Florida | 33607 | 813-374-0568 Leopoldo Grauer (PRINCIPAL_INVESTIGATOR) |
| Research Bay,Inc. | Tampa | Florida | 33607 | 813-304-1265 Mina Elnemr (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | 312-695-5878 Keith Summa (PRINCIPAL_INVESTIGATOR) |
| Avicenna Clinical Research - SW Gastroenterology | Oak Lawn | Illinois | 60453-3754 | 708-499-5678 Charles Berkelhammer (PRINCIPAL_INVESTIGATOR) |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | 504-455-1310 David Dulitz (PRINCIPAL_INVESTIGATOR) |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | 49519 | 616-328-5344 Allan Coates (PRINCIPAL_INVESTIGATOR) |
| Ellipsis Research Group | Brooklyn | New York | 11215 | 347-422-0317 Jorge Serje (PRINCIPAL_INVESTIGATOR) |
| Smart Medical Research - Jackson Heights | Jackson Heights | New York | 11372 | 718-305-1900 Gulam Khan (PRINCIPAL_INVESTIGATOR) |
| Pioneer Clinical Research NY | New York | New York | 10012-3645 | 917-977-0900 Murray Orbuch (PRINCIPAL_INVESTIGATOR) |
| Digestive Disease Medicine of Central New York | Utica | New York | 13502 | 315-624-7035 Harvey Allen (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | 919-445-3880 Animesh Jain (PRINCIPAL_INVESTIGATOR) |
| GCGA Physicians, LLC dba / Gastro Health Research | Cincinnati | Ohio | 45219 | 513-872-4549 Pradeep Bekal (PRINCIPAL_INVESTIGATOR) |
| NexGen Research | Lima | Ohio | 45801 | 419-516-0954 Ext 105 Nonso Ezema (PRINCIPAL_INVESTIGATOR) |
| Inquest Clinical Research | Baytown | Texas | 77521 | 281-428-8203 Haider Afzal (PRINCIPAL_INVESTIGATOR) |
| DHR Health Gastroenterology - Edinburg | Edinburg | Texas | 78539 | 956-362-2356 Murthy Badiga (PRINCIPAL_INVESTIGATOR) |
| Baylor College of Medicine | Houston | Texas | 77030 | 713-798-7616 Jason Hou (PRINCIPAL_INVESTIGATOR) |
| Intergrity Research | Houston | Texas | 77043 | 832-860-0720 Mouhamad Al-Sabbagh (PRINCIPAL_INVESTIGATOR) |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | 210-615-3848 Nicholas Martinez (PRINCIPAL_INVESTIGATOR) |
| Tyler Research Institute | Tyler | Texas | 75701 | 903-630-6211 George Duvall (PRINCIPAL_INVESTIGATOR) |
| Advanced Research Institute - South Ogden | Ogden | Utah | 84405 | 801-409-2040 John Lowe (PRINCIPAL_INVESTIGATOR) |
| Care Access-Ogden | Ogden | Utah | 84403 | 801-614-0010 Chad Gonzales (PRINCIPAL_INVESTIGATOR) |
| University of Washington School Medicine | Seattle | Washington | 98195 | 206-543-3500 Scott Lee (PRINCIPAL_INVESTIGATOR) |
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