A Crohn's Disease study

• Register: EUCTR
• Last refreshed on: 19 April 2021
• Main ID: EUCTR2016-002204-84-BE
• Date of registration: 06/02/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Crohn's Disease study
• Scientific title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)
• Date of first enrolment: 02/05/2017
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002204-84
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, France, Hungary, Japan, Moldova, Republic of, Netherlands, Poland, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
• Active Crohn's Disease (CD) as determine 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, azathiopurine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: LY3074828
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: Not assigned
Current Sponsor code: LY3074828
Other descriptive name: LY3074828
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To test the hypothesis that treatment with LY3074828 is superior to placebo in the proportion of subjects with endoscopic response at Week 12, defined as 50% reduction from baseline in SES-CD
Score

Primary end point(s): Proportion of Participants Achieving 50% Reduction from Baseline on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD)

Secondary Objective: Evaluate safety & tolerability of treatment with LY3074828
Evaluate effect of LY3074828 on the proportion of subjects with endoscopic response at Wk 52, defined as 50% reduction from baseline SES-CD score
Evaluate efficacy of LY3074828 as superior to placebo in endoscopicremission (defined as SES-CD score of <4 ilealcolonic or <2 for isolated ileal disease & no subscore >1) at Wk 12
Evaluate effect of LY3074828 on proportion of subjects with endoscopic remission (defined as SES-CD score of <4 ileal-colonic or
<2 for isolated ileal disease & no subscore >1) at Wk 52
Evaluate efficacy of treatment with LY3074828 as superior to placebo in PRO remission (defined SF =2.5 and AP =1) at Wk 12
Evaluate effect of LY3074828 on the proportion of subjects with PRO remission (defined SF =2.5 & AP =1) at Wk 52
Evaluate the effect of LY3074828 on health outcomes/quality of life measures (including: PGRS/PGRC/IBDQ & SF-36 score & FACIT-Fatigue) at Wks 12 & 52
Characterize the PK of LY3074828

Timepoint(s) of evaluation of this end point: Time Frame: Week 12

Secondary Outcome(s)

Secondary end point(s): • Discontinuation Rate
• Proportion of Participants Achieving Endoscopic Remission
• Proportion of Participants Achieving Patient Report Outcome Remission
• Mean Change from Baseline on the Patient Global Rating - Severity
(PGRS) Crohn's Disease Score
• Mean Change from Baseline on the Patient Global Rating - Change
(PGRC) Crohn's Disease Score
• Mean Change from Baseline on the Inflammatory Bowel Disease
Questionnaire (IBDQ) Score
• Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
• Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score
• Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3074828

Timepoint(s) of evaluation of this end point: Time Frame: Baseline through Week 104
Time Frame: Week 12
Time Frame: Week 12
Time Frame: Baseline, Week 12
Time Frame: Baseline, Week 12
Time Frame: Baseline, Week 12
Time Frame: Baseline, Week 12
Time Frame: Baseline, Week 12
Time Frame: Baseline through Week 104

Secondary ID(s)

2016-002204-84-GB

I6T-MC-AMAG

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 02/05/2017
Contact: