EUCTR2017-004092-31-PLActive, not recruitingPhase 1
I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 840
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients from the Phase 2 Study AMAC who in the opinion of the investigator, would derive benefit from
- •treatment with mirikizumab
- •2. Patients from the Phase 3 Study AMBG who in the opinion of the investigator, would derive benefit from
- •treatment with mirikizumab.
- •3. If female, must meet the contraception requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 756
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
Exclusion Criteria
- •1. Would not, in the opinion of the investigator, derive clinical benefit
- •from open-label treatment with mirikizumab.
- •2. Had a reported SAE in originator study or developed other condition
- •prior to Week 0 visit that would disqualify them from treatment with
- •mirikizumab according to originator study criteria.
- •3. Are diagnosed with any medical condition including developing
- •malignancy or suspicion of active malignant disease during the
- •originator study or prior to Week 0, which would have precluded
- •enrollment in a prior mirikizumab study or would have required
- •discontinuation.
- •4. Participants diagnosed with clinically important infection including,
- •but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active
- •tuberculosis (TB) during either originator study.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study of the efficacy and safety of Mirikizumab in Ulcerative Colitismoderately to severely active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004092-31-DKEli Lilly and Company960
Active, not recruiting
Phase 1
A study of the efficacy and safety of Mirikizumab in Ulcerative Colitismoderately to severely active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004092-31-BEEli Lilly and Company960
Active, not recruiting
Phase 1
A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisEUCTR2017-004092-31-DEEli Lilly and Company960
Active, not recruiting
Phase 1
A study of the efficacy and safety of Mirikizumab in Ulcerative Colitismoderately to severely active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004092-31-LTEli Lilly and Company960
Active, not recruiting
Phase 1
A study of the efficacy and safety of Mirikizumab in Ulcerative Colitismoderately to severely active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004092-31-GBEli Lilly and Company840