A Study of LY3361237 in Participants With Psoriasis

NCT04975295 | Completed Phase 1

• 3 other identifiers: 17291I9S-MC-BTAC2019-003187-40
• Study Type: interventional
• Target: 21
• Locations: 4 countries
• Sites: 7

Brief Summary

The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 visits to the study center.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 253

Secondary Outcomes (1)

• Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval

  Day 1 predose through Day 253

Study Arms (2)

LY3361237

EXPERIMENTAL

LY3361237 administered subcutaneously (SC).

Drug: LY3361237

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3361237 DRUG

Administered SC

LY3361237

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have chronic plaque psoriasis for at least 6 months
• Be willing and able to undergo skin biopsies
• Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
• Female participants must agree to use birth control during the study

You may not qualify if:

• Have had certain types of infection within the last six months
• Have a clinically significant active infection, or recent acute active infection within the last 30 days
• Have other serious or unstable illnesses
• Have a history of organ or bone marrow transplant
• Have received any live vaccine within the last 4 weeks prior to screening
• Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
• Have received topical psoriasis treatment within 14 days prior to study day 1
• Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

MC Comac Medical

Sofia, 1606, Bulgaria

Location

Budai Irgalmasrendi Korhaz

Budapest, 1027, Hungary

Location

All Med - Lodz

Lodz, 94048, Poland

Location

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

Poznan, 61-113, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Pratia - Warsaw

Warsaw, 01-868, Poland

Location

Summit Clinical Research, s.r.o. - Bratislava

Bratislava, 831, Slovakia

Location

Related Links

• A Study of LY3361237 in Participants With Psoriasis

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 23, 2021
• Study Start: July 27, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); PL (4); SL (1); HU (1)