Ulcerative ColitisPhase 3LUCENT-ACTNCT04469062
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
A Phase 3 study testing Mirikizumab IV, Mirikizumab SC and Vedolizumab IV in people with Ulcerative Colitis, run by Eli Lilly and Company.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mirikizumab IV, Mirikizumab SC and Vedolizumab IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2021to 5 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a diagnosis of UC for at least 3 months prior to baseline
- Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
- Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
- Participants must, if female, meet the contraception requirements
Who cannot join
- Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
- Participants must not have had a previous colectomy
- Participants must not have current evidence of toxic megacolon
- Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
- Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
About this study
Official title: A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis
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).
- Conditions
- Ulcerative Colitis
- Being tested
- Mirikizumab IV, Mirikizumab SC, Vedolizumab IV, Placebo IV, Placebo SC
- Keywords
- Interleukin-23 (IL-23) antibody, IL-23p19
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab IVDrug
Also called LY3074828
Administered IV
Mirikizumab SCDrug
Also called LY3074828
Administered SC
Vedolizumab IVDrug
Administered IV
Placebo IVDrug
Administered IV
Placebo SCDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab | Experimental | Mirikizumab administered intravenously (IV) and subcutaneously (SC). Receives: Drug: Mirikizumab IV; Drug: Mirikizumab SC |
| Vedolizumab | Active comparator | Vedolizumab administered IV. Receives: Drug: Vedolizumab IV |
| Placebo | Placebo comparator | Placebo administered SC and IV. Receives: Drug: Placebo IV; Drug: Placebo SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Histologic Remission
Histologic remission based on histology.
Measured: Week 12
Secondary outcomes (9)
Percentage of Participants in Symptomatic Remission
Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
Measured: Week 52
Percentage of Participants in Clinical Remission
Clinical remission based on MMS.
Measured: Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission based on MMS ES.
Measured: Week 52
Percentage of Participants with Clinical Response
Clinical response based on MMS.
Measured: 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.
Measured: 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.
Measured: Week 52
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change from baseline on the IBDQ score.
Measured: Baseline, Week 52
Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
Percentage of participants undergoing surgery for UC (including colectomy).
Measured: Week 52
Percentage of Participants Hospitalized for UC
Percentage of participants hospitalized for UC.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start20 Apr 2021 (estimated)
- Primary completion13 Mar 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Why it stopped: The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469062
- Sponsor's protocol ID
- 16825
- Other IDs
- I6T-MC-AMBI, 2019-001653-99, 2019
- Acronym
- LUCENT-ACT
- Status last verified
- May 2021
- First submitted
- 10 Jul 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04469062
- Acronym / sponsor ID
- LUCENT-ACT / 16825
- Conditions
- Ulcerative Colitis
- Keywords
- Interleukin-23 (IL-23) antibody, IL-23p19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 13 Mar 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab | Experimental | Drug: Mirikizumab IV, Drug: Mirikizumab SCMirikizumab administered intravenously (IV) and subcutaneously (SC). |
| Vedolizumab | Active comparator | Drug: Vedolizumab IVVedolizumab administered IV. |
| Placebo | Placebo comparator | Drug: Placebo IV, Drug: Placebo SCPlacebo administered SC and IV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a diagnosis of UC for at least 3 months prior to baseline
- Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
- Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
- Participants must, if female, meet the contraception requirements
Key exclusion criteria (5 listed)
- Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
- Participants must not have had a previous colectomy
- Participants must not have current evidence of toxic megacolon
- Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
- Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirikizumab IVAlso: LY3074828Administered IV | Drug | Mirikizumab |
| Mirikizumab SCAlso: LY3074828Administered SC | Drug | Mirikizumab |
| Vedolizumab IVAdministered IV | Drug | Vedolizumab |
| Placebo IVAdministered IV | Drug | Placebo |
| Placebo SCAdministered SC | Drug | Placebo |
Primary outcome
Percentage of Participants in Histologic Remission
Time frame: Week 12
Histologic remission based on histology.
9 secondary outcomes
Percentage of Participants in Symptomatic Remission
Time frame: Week 52
Percentage of Participants in Clinical Remission
Time frame: Week 52
Percentage of Participants in Endoscopic Remission
Time frame: Week 52
Percentage of Participants with Clinical Response
Time frame: Week 12
Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
Time frame: Week 52
Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
Time frame: Week 52
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Baseline, Week 52
Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
Time frame: Week 52
Percentage of Participants Hospitalized for UC
Time frame: Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirikizumab IV, Mirikizumab SC and Vedolizumab IV in people with Ulcerative Colitis, run by Eli Lilly and Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Histologic Remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.