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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02891226




Registration number
NCT02891226
Ethics application status
Date submitted
1/09/2016
Date registered
7/09/2016
Date last updated
24/03/2021

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Scientific title
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Secondary ID [1] 0 0
I6T-MC-AMAG
Secondary ID [2] 0 0
16492
Universal Trial Number (UTN)
Trial acronym
SERENITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Placebo

Experimental: Mirikizumab Dose Level 1 - Period 1 (Weeks 0 -12) Mirikizumab dose level 1
Period 2 (Weeks 12 - 52) Mirikizumab dose level 1 or dose level 4 or dose level 3
Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Experimental: Mirikizumab Dose Level 2 - Period 1 (Weeks 0 -12) Mirikizumab dose level 2
Period 2 (Weeks 12 - 52) Mirikizumab dose level 2 or dose level 4 or dose level 3
Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Experimental: Mirikizumab Dose Level 3 - Period 1 (Weeks 0 -12) Mirikizumab dose level 3
Period 2 (Weeks 12 - 52) Mirikizumab dose level 3 or dose level 4
Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Placebo Comparator: Placebo - Period 1 (Weeks 0 -12) Placebo
Period 2 (Weeks 12 - 52) Mirikizumab dose level 3
Period 3 (Weeks 52 - 104) Mirikizumab dose level 4


Treatment: Drugs: Mirikizumab


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Achieving 50% Reduction from Baseline on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Discontinuation Rate
Timepoint [1] 0 0
Baseline through Week 104
Secondary outcome [2] 0 0
Proportion of Participants Achieving Endoscopic Remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of Participants Achieving Patient Report Outcome Remission
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Mean Change from Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Mean Change from Baseline on the Patient Global Rating - Change (PGRC) Crohn's Disease Score
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Mean Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
Timepoint [9] 0 0
Baseline through Week 104

Eligibility
Key inclusion criteria
- Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported
stool frequency and abdominal pain.

- Inadequate response or failure to tolerate at least one of the following:
aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg,
azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for
the treatment of CD.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have complications of CD such as strictures, stenoses, or any other manifestation for
which surgery might be indicated, or that could confound the evaluation of efficacy.

- Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis,
indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous
colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.

- Have had any kind of bowel resection, diversion, or placement of a stoma within 6
months or any other intra-abdominal surgery within 3 months prior to screening.

- Are unsuitable for inclusion in the study in the opinion of the investigator or
sponsor for any reason that may compromise the subject's safety or confound data
interpretation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Ballarat Health Services - Base Hospital - Ballarat
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
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Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug
Mirikizumab in participants with active Crohn's Disease.
Trial website
https://clinicaltrials.gov/show/NCT02891226
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications