A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Study Purpose

This study designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

  • - Inclusion Criteria - Participants from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) who have had at least one study drug administration and have not had early termination of study drug.
  • - Female participants must agree to contraception requirements.
  • - Exclusion Criteria - Participants must not have developed a new condition, including cancer in the originator study.
  • - Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study - Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
  • - Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03519945

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Eli Lilly and Company

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation Eli Lilly and Company

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Croatia, Czechia, Denmark, Georgia, Hungary, Ireland, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic of, Netherlands, Poland, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, La Jolla, California

Status

Not yet recruiting

Address

University of California San Diego

La Jolla, California, 92093

Site Contact

858-657-5284

Inland Empire Liver Foundation, Rialto, California

Status

Recruiting

Address

Inland Empire Liver Foundation

Rialto, California, 92377

Site Contact

909-883-2999

Borland Groover Clinic, Jacksonville, Florida

Status

Recruiting

Address

Borland Groover Clinic

Jacksonville, Florida, 32256 6004

Site Contact

904-398-3262

Delta Research Partners LLC, Monroe, Louisiana

Status

Recruiting

Address

Delta Research Partners LLC

Monroe, Louisiana, 71201

Site Contact

318-283-2177

University of Michigan, Ann Arbor, Michigan

Status

Not yet recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

734-647-2964

Minnesota Gastroenterology, P.A., Plymouth, Minnesota

Status

Recruiting

Address

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446

Site Contact

612-870-5599

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Site Contact

212-831-4900

Care Access Research - Salt Lake City, Salt Lake City, Utah

Status

Recruiting

Address

Care Access Research - Salt Lake City

Salt Lake City, Utah, 84124

Site Contact

801-893-1788

International Sites

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

Site Contact

61731767792

St Vincents Hospital Melbourne, Fitzroy, Victoria, Australia

Status

Recruiting

Address

St Vincents Hospital Melbourne

Fitzroy, Victoria, 3065

Site Contact

61392313580

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Site Contact

3293325166

Leuven, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , 3000

Site Contact

3216348856

Montreal, Quebec, Canada

Status

Not yet recruiting

Address

CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital

Montreal, Quebec, H1T 2M4

Site Contact

5142523400

McGill University, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

McGill University

Montreal, Quebec, H3G 1A4

Site Contact

5149341934

University Hospital Center Osijek, Osijek, Croatia

Status

Not yet recruiting

Address

University Hospital Center Osijek

Osijek, , 31000

Site Contact

38531511101

University Hospital Split, Split, Croatia

Status

Not yet recruiting

Address

University Hospital Split

Split, , 21000

Site Contact

385959017430

CHC Zagreb, Zagreb, Croatia

Status

Not yet recruiting

Address

CHC Zagreb

Zagreb, , 10000

Site Contact

38512388888

Clinical Hospital Sveti Duh, Zagreb, Croatia

Status

Not yet recruiting

Address

Clinical Hospital Sveti Duh

Zagreb, , 10000

Site Contact

38513712226

Polyclinic Bonifarm, Zagreb, Croatia

Status

Not yet recruiting

Address

Polyclinic Bonifarm

Zagreb, , 10000

Site Contact

38516461170

Zagreb, Croatia

Status

Not yet recruiting

Address

University Hospital Center Sestre Milosrdnice

Zagreb, , 10000

Site Contact

385994430566

Hepato-gastroenterologie HK, s.r.o., Hradec Kralove, Czechia

Status

Recruiting

Address

Hepato-gastroenterologie HK, s.r.o.

Hradec Kralove, , 50012

Site Contact

420495404485

Nyborg Sygehus - OUH, Nyborg, Denmark

Status

Not yet recruiting

Address

Nyborg Sygehus - OUH

Nyborg, , 5800

Site Contact

4563312906

LLC ARENSIA Exploratory Medicine, Tbilisi, Georgia

Status

Recruiting

Address

LLC ARENSIA Exploratory Medicine

Tbilisi, , 0112

Site Contact

995599171517

Dr. Rethy Pal Korhaz es Rendelointezet, Bekescsaba, Bekes, Hungary

Status

Not yet recruiting

Address

Dr. Rethy Pal Korhaz es Rendelointezet

Bekescsaba, Bekes, 5600

Site Contact

36309159350

Budapest, Hungary

Status

Not yet recruiting

Address

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, , 1125

Site Contact

3614584533

SZTE I. sz. Belgyogyaszati Klinika, Szeged, Hungary

Status

Not yet recruiting

Address

SZTE I. sz. Belgyogyaszati Klinika

Szeged, , 6720

Site Contact

3662545185

Clinfan Szolgaltato Kft., Szekszard, Hungary

Status

Recruiting

Address

Clinfan Szolgaltato Kft.

Szekszard, , 7100

Site Contact

3674501500

Javorszky Odon Hospital, Vac, Hungary

Status

Recruiting

Address

Javorszky Odon Hospital

Vac, , 2600

Site Contact

3627620620

Beaumont Hospital, Dublin, Ireland

Status

Not yet recruiting

Address

Beaumont Hospital

Dublin, , DUBLIN 9

Site Contact

35318377755

Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Sapporo-shi, Hokkaido, 060 0033

Site Contact

81120360605

Nishinomiya, Hyogo, Japan

Status

Recruiting

Address

The Hospital of Hyogo College of Medecine

Nishinomiya, Hyogo, 663-8501

Site Contact

81120360605

Sameshima Hospital, Kagoshima-shi, Kagoshima, Japan

Status

Recruiting

Address

Sameshima Hospital

Kagoshima-shi, Kagoshima, 892-0846

Site Contact

81120360605

Gokeikai Ofuna Chuo Hospital, Kamakura-shi, Kanagawa, Japan

Status

Recruiting

Address

Gokeikai Ofuna Chuo Hospital

Kamakura-shi, Kanagawa, 247-0056

Site Contact

81120360605

Kawasaki Municipal Kawasaki Hospital, Kawasaki, Kanagawa, Japan

Status

Recruiting

Address

Kawasaki Municipal Kawasaki Hospital

Kawasaki, Kanagawa, 210-0013

Site Contact

81120360605

Matsushima Clinic, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Matsushima Clinic

Yokohama, Kanagawa, 220 0045

Site Contact

81120360605

Kinshukai Infusion Clinic, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Kinshukai Infusion Clinic

Osaka-shi, Osaka, 530 0011

Site Contact

81120360605

Saga-Ken Medical Center Koseikan, Saga-shi, Saga, Japan

Status

Recruiting

Address

Saga-Ken Medical Center Koseikan

Saga-shi, Saga, 840 8571

Site Contact

81120360605

Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Tokyo, 113-8519

Site Contact

81120360605

Kyorin University Hospital, Mitaka, Tokyo, Japan

Status

Recruiting

Address

Kyorin University Hospital

Mitaka, Tokyo, 181-8611

Site Contact

81120360605

JHCO Tokyo Yamate Medical Center, Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

JHCO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo, 169-0073

Site Contact

81120360605

Toyama Prefectural Central Hospital, Toyama-Shi, Toyama, Japan

Status

Recruiting

Address

Toyama Prefectural Central Hospital

Toyama-Shi, Toyama, 930-8550

Site Contact

81120360605

Riga, Latvia

Status

Not yet recruiting

Address

Pauls Stradins Kliniska Universitates Slimnica

Riga, , LV-1002

Site Contact

3717069509

Riga, Latvia

Status

Not yet recruiting

Address

Health Center 4, Affiliate Diagnostic Center

Riga, , LV-1003

Site Contact

37126588961

Digestive Diseases Center "Gastro", Riga, Latvia

Status

Not yet recruiting

Address

Digestive Diseases Center "Gastro"

Riga, , LV-1006

Site Contact

37129245443

Riga, Latvia

Status

Not yet recruiting

Address

Riga Eastern Clinical University Hospital

Riga, , LV-1038

Site Contact

37129527746

Kaunas, Lithuania

Status

Recruiting

Address

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, , 50161

Site Contact

37068568861

Republic Hospital of Klaipeda, Klaipeda, Lithuania

Status

Not yet recruiting

Address

Republic Hospital of Klaipeda

Klaipeda, , 92231

Site Contact

37062046677

Klaipeda Seamen's Hospital, Klaipeda, Lithuania

Status

Not yet recruiting

Address

Klaipeda Seamen's Hospital

Klaipeda, , 92288

Site Contact

37068712367

Respublikine Panevezio Ligonine, Panevezys, Lithuania

Status

Not yet recruiting

Address

Respublikine Panevezio Ligonine

Panevezys, , LT-35144

Site Contact

37067035353

Vilnius, Lithuania

Status

Recruiting

Address

Vilniaus Universiteto Ligonines Santariskiu Klinikos

Vilnius, , LT-08661

Site Contact

37068825454

Hospital Sultanah Bahiyah, Alor Star, Kedah, Malaysia

Status

Not yet recruiting

Address

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460

Site Contact

6047406227

Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan, Malaysia

Status

Not yet recruiting

Address

Hospital Raja Perempuan Zainab II

Kota Bahru, Kelantan, 15586

Site Contact

60139395880

Cheras, Kuala Lumpur, Malaysia

Status

Not yet recruiting

Address

Pusat Perubatan University Kebangsaan Malaysia

Cheras, Kuala Lumpur, , 56000

Site Contact

60124500026

Hospital Universiti Sains Malaysia, Kelantan, Malaysia

Status

Not yet recruiting

Address

Hospital Universiti Sains Malaysia

Kelantan, , 16150

Site Contact

6097676595

University Malaya Medical Centre, Kuala Lumpur, Malaysia

Status

Not yet recruiting

Address

University Malaya Medical Centre

Kuala Lumpur, , 59100

Site Contact

60379492966

University Malaya Medical Centre, Kuala Lumpur, Malaysia

Status

Not yet recruiting

Address

University Malaya Medical Centre

Kuala Lumpur, , 59100

Site Contact

6042225768

Republican Clinical Hospital, Chisinau, Moldova, Republic of

Status

Recruiting

Address

Republican Clinical Hospital

Chisinau, , MD2025

Site Contact

1137379689636

Academisch Medisch Centrum, Amsterdam, Netherlands

Status

Recruiting

Address

Academisch Medisch Centrum

Amsterdam, , 1105 AZ

Site Contact

31205666545

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 2 im. dr J. Biziela

Bydgoszcz, , 85-168

Site Contact

48523655106

Szpital Miejski Sw. Jana Pawla II, Elblag, Poland

Status

Recruiting

Address

Szpital Miejski Sw. Jana Pawla II

Elblag, , 82-300

Site Contact

48606204848

Katowice, Poland

Status

Not yet recruiting

Address

NZOZ ALL-MEDICUS, Zaklad Gastroenterologii

Katowice, , 40-659

Site Contact

48602372597

Gabinet Endoskopii Przewodu Pokarmowego, Krakow, Poland

Status

Recruiting

Address

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, , 31009

Site Contact

48124212520

NZOZ Gastromed, Lublin, Poland

Status

Recruiting

Address

NZOZ Gastromed

Lublin, , 20-582

Site Contact

48795404502

Rzeszow, Poland

Status

Recruiting

Address

Centrum Medyczne Lux Med Poradnia Gastroenterologii

Rzeszow, , 35-068

Site Contact

48608446952

Endoskopia sp z o. o, Sopot, Poland

Status

Recruiting

Address

Endoskopia sp z o. o

Sopot, , 81-756

Site Contact

48585552631

Vivamed, Warszawa, Poland

Status

Recruiting

Address

Vivamed

Warszawa, , 03-580

Site Contact

48601322352

John Radcliffe Hospital, Headington, Oxfordshire, United Kingdom

Status

Recruiting

Address

John Radcliffe Hospital

Headington, Oxfordshire, OX3 9DU

Site Contact

441865228753

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