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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02589665




Registration number
NCT02589665
Ethics application status
Date submitted
27/10/2015
Date registered
28/10/2015
Date last updated
17/06/2020

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Scientific title
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
I6T-MC-AMAC
Secondary ID [2] 0 0
15829
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 50 mg Mirikizumab IV Q4W (Induction) - 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Experimental: 200 mg Mirikizumab IV Q4W (induction) - 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Experimental: 600 mg Mirikizumab IV Q4W (Induction) - 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Placebo comparator: Placebo IV Q4W (Induction) - Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

Experimental: 200 mg Mirikizumab SC Q4W (Maintenance) - Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.

Experimental: 200 mg Mirikizumab SC Q12W (Maintenance) - Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.

Placebo comparator: Placebo SC Q4W (Maintenance) - Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.

Experimental: 600mg Mirikizumab IV Q4W Extension Open-Label - Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

Experimental: 1000mg Mirikizumab IV Q4W Extension Open-Label - Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

Experimental: 200mg Mirikizumab SC Q4W Extension Open-Label - Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Period: Percentage of Participants With Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Induction Period: Percentage of Participants With Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
Timepoint [8] 0 0
Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d
Secondary outcome [9] 0 0
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
Timepoint [12] 0 0
Week 52

Eligibility
Key inclusion criteria
* Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore =2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
* Have evidence of UC extending proximal to the rectum (=15 centimeters [cm] of involved colon)
* Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
* Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
* Have had surgery for treatment of UC or are likely to require surgery for UC during the study
* Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

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
9/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2019
Sample size
Target
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Concord
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - South Brisbane
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Belgium
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Ghent
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Belgium
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Leuven
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Canada
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Calgary
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Canada
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Montreal
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Canada
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Montréal
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Czechia
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Hradec Kralove
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Czechia
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Hradec Králové
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Czechia
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Praha 4 Kralove
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Czechia
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Praha 4
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Czechia
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Praha
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Denmark
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Svendborg
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France
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Clichy
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France
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Montpellier Cedex 5
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France
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Nice
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France
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Saint Priest en Jarez
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France
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Vandoeuvre Les Nancy
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Georgia
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Tbilisi
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Szeged
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Hungary
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Szekszard
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Hungary
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Vac
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Kagoshima-shi
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Japan
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Kamakura-shi
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Japan
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Kasugai-shi
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Japan
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Kawasaki
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Japan
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Mitaka
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Japan
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Nishinomiya
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Japan
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Oita City
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Japan
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Osaka-City
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Japan
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Saga-shi
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Japan
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Sakura
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Japan
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Shinjuku-ku
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Japan
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Takasaki
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Japan
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Toyama
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Japan
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Toyota-shi
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Japan
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Tsu-shi
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Japan
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Yokohama
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Moldova, Republic of
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Chisinau
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Netherlands
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Amsterdam
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Katowice
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Krakow
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Lublin
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Rzeszow
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Sopot
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Warszawa
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Wroclaw
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Romania
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Bucharest
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United Kingdom
State/province [64] 0 0
Oxford
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United Kingdom
State/province [65] 0 0
Winchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.
Trial website
https://clinicaltrials.gov/study/NCT02589665
Trial related presentations / publications
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02589665