A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody, in Patients with Moderate-to-Severe Ulcerative Colitis (Protocol # I6T-MC-AMAC)
Published: 07/18/2017
General Information:
The primary objective of this study is to test the hypothesis that treatment with LY3074828 is superior to placebo in inducing clinical remission at Week 12 in subjects with moderate to severe ulcerative colitis (UC). The secondary objectives are: -To evaluate the safety and tolerability of treatment with LY3074828. -To evaluate the efficacy of treatment with LY3074828 in inducing a clinical response at Week 12. -To evaluate endoscopic remission at Week 12 and Week 52. -To evaluate the effect of maintenance treatment with LY3074828 on the durability of clinical remission, endoscopic remission, and clinical response at Week 52. -To evaluate the effect of LY3074828 on health outcomes/quality of life measures. -To characterize the pharmacokinetic (PK) profile of LY3074828.
Eligibility:
This study will include male or female subjects ≥18 and ≤75 years of age with moderate to severe active UC. Patients must either have:
- Inadequate response or failure to tolerate treatment with aminosalicylates, 6-mercaptopurine (6-MP) or Azathioprine (AZA), or corticosteroids
- Or have received treatment with 1 or more biologic agents at doses approved for the treatment of UC
Patients may remain on stable doses of oral aminosalicylates, 6-MP or AZA, or corticosteroids according to the protocol.
Study Details:
Study Description
Overview of Study Design: Lilly study I6T-MC-AMAC is phase 2, multicenter, randomized, double-blind, parallel-arm, placebo controlled trial in which approximately 240 subjects will be randomized. Patients must have moderate or severe Ulcerative Colitis.
Description of Treatment or Intervention (Mechanism of Action)
The study drug: LY3074828 (IL-23)
Mechanism of Action:
- LY3074828 is a humanized immunoglobulin G4-variant monoclonal antibody that is directed against the p19 subunit of IL-23. IL-23 causes immune cells (Th17, macrophages) to make substances (cytokines) that injure the intestine. LY3074828 blocks IL-23 so it can’t activate the immune cells and cytokines that damage the intestine.
Patient Participation Requirements
The UC study will include:
- A 4-week Screening Period
- A 12week Induction Period
- A Maintenance Period for those subjects having a clinical response at Week 12 up through Week 52. Subjects who do not meet clinical response criteria at Week 12 will have the option to continue in a study Extension Period or discontinue from the study.
- An optional Extension period if certain criteria are met. Subjects will receive study-related procedures and study drug at no cost. Additionally, subject will receive monitoring by the study doctor and staff for the duration of the study.
Possible Risks & Side Effects
LY3074828 has been studied in humans.
Possible side effects and risks include:
- Common cold
- Headache
- Nausea
- Diarrhea
- Pain at injection site
- Increased chance of infection
- Allergic reaction
The effects of LY3074828 on pregnancy are unknown. If you are or you may become pregnant or are breastfeeding, you should not participate in studies with LY3074828. Men and women of child bearing potential should use a reliable method of birth control during the study and for 3 months after the last dose of study drug. For further questions or clarifications on the possible risks and side effects, please consult your study doctor.