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NCT Number: NCT03519945

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

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mautalen Salud e Investigación, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria
  • Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) 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.

Treatment and study plan

Mirikizumab

Drug

Administered SC.

Other names: LY3074828

Primary outcomes

  1. Percentage of Participants in Clinical Remission

    Time frame: Week 52

    Clinical remission based on the modified Mayo Score (MMS).

Secondary outcomes

  1. Percentage of Participants in Endoscopic Remission

    Time frame: Week 52

    Endoscopic remission based on the MMS Endoscopic Subscore (ES).

  2. Percentage of Participants in Corticosteroid-free Remission

    Time frame: Week 52

    Participants in corticosteroid-free remission.

  3. Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52

    Time frame: Week 52

    Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.

  4. Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score

    Time frame: Baseline to Week 52

    Health Related Quality of Life based on IBDQ score.

  5. UC Symptoms: Numeric Rating Score

    Time frame: Week 160

    UC symptoms based on numeric rating score.

  6. Percentage of Participants Who are Hospitalized Due to UC

    Time frame: Baseline to Week 160

    Participants who are hospitalized due to UC.

  7. Percentage of Participants Who Undergo UC Surgeries Including Colectomy

    Time frame: Baseline to Week 160

    Participants who undergo UC surgeries including colectomy.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
May 9, 2018
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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