A Phase 3 interventional study of Mirikizumab IV and Mirikizumab SC in Ulcerative Colitis, sponsored by Eli Lilly and Company. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
Browse Colitis studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Drug: Mirikizumab IV · Drug: Mirikizumab SC
Vedolizumab administered IV.
Drug: Vedolizumab IV
Placebo administered SC and IV.
Drug: Placebo IV · Drug: Placebo SC
Administered IV
Also known as: LY3074828
Administered SC
Also known as: LY3074828
Administered IV
Administered IV
Administered SC
Percentage of Participants in Histologic Remission
Histologic remission based on histology.
Time frame: Week 12
Percentage of Participants in Symptomatic Remission
Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
Time frame: Week 52
Percentage of Participants in Clinical Remission
Clinical remission based on MMS.
Time frame: Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission based on MMS ES.
Time frame: Week 52
Percentage of Participants with Clinical Response
Clinical response based on MMS.
Time frame: Week 12
Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.
Time frame: Week 52
Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
Percentage of participants with resolution of EIMs among those that had them at baseline.
Time frame: Week 52
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change from baseline on the IBDQ score.
Time frame: Baseline, Week 52
Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
Percentage of participants undergoing surgery for UC (including colectomy).
Time frame: Week 52
Percentage of Participants Hospitalized for UC
Percentage of participants hospitalized for UC.
Time frame: Week 52
No study locations are listed for this record.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company