Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02891226
Ethics application status
Date submitted
1/09/2016
Date registered
7/09/2016

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
Experimental: Mirikizumab - Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W).

Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1.

Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.

Placebo comparator: Placebo - Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
Timepoint [8] 0 0
Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion
Secondary outcome [9] 0 0
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
Timepoint [9] 0 0
Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion

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
Sex
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
14/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2021
Sample size
Target
Accrual to date
Final
191
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussel
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Czechia
State/province [29] 0 0
Czech Republic
Country [30] 0 0
Czechia
State/province [30] 0 0
Hradec Kralove
Country [31] 0 0
Czechia
State/province [31] 0 0
Olomouc
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 4 - Krc
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 5
Country [34] 0 0
Czechia
State/province [34] 0 0
Zlin
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Vac
Country [37] 0 0
Japan
State/province [37] 0 0
Chiba-Ken
Country [38] 0 0
Japan
State/province [38] 0 0
Fukoka
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka-Ken
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido
Country [41] 0 0
Japan
State/province [41] 0 0
Kagoshima
Country [42] 0 0
Japan
State/province [42] 0 0
Kanagawa
Country [43] 0 0
Japan
State/province [43] 0 0
Miyagi-Ken
Country [44] 0 0
Japan
State/province [44] 0 0
Osaka-Fu
Country [45] 0 0
Japan
State/province [45] 0 0
Tokyo
Country [46] 0 0
Japan
State/province [46] 0 0
Toyama
Country [47] 0 0
Japan
State/province [47] 0 0
Fukuoka
Country [48] 0 0
Netherlands
State/province [48] 0 0
Noord Brabant
Country [49] 0 0
Netherlands
State/province [49] 0 0
Amsterdam
Country [50] 0 0
Netherlands
State/province [50] 0 0
Nijmegen
Country [51] 0 0
Netherlands
State/province [51] 0 0
Rotterdam
Country [52] 0 0
Poland
State/province [52] 0 0
Bydgoszcz
Country [53] 0 0
Poland
State/province [53] 0 0
Lublin
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
Country [55] 0 0
Poland
State/province [55] 0 0
Rzeszow
Country [56] 0 0
Poland
State/province [56] 0 0
Szczecin
Country [57] 0 0
Poland
State/province [57] 0 0
Warszawa
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Romania
State/province [59] 0 0
Bihor
Country [60] 0 0
Romania
State/province [60] 0 0
Bucuresti
Country [61] 0 0
Romania
State/province [61] 0 0
Timisoara
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Novosibirsk
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Omsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Perm
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Pushkin
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Samara
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St. Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ulyanovsk
Country [69] 0 0
Switzerland
State/province [69] 0 0
Zürich
Country [70] 0 0
Ukraine
State/province [70] 0 0
Kyiv
Country [71] 0 0
Ukraine
State/province [71] 0 0
Lviv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Odesa
Country [73] 0 0
Ukraine
State/province [73] 0 0
Uzhgorod
Country [74] 0 0
Ukraine
State/province [74] 0 0
Vinnytsia
Country [75] 0 0
Ukraine
State/province [75] 0 0
Vinnytsya
Country [76] 0 0
Ukraine
State/province [76] 0 0
Zaporizhzhia
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02891226