A Study of LY3361237 in Participants With Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Participants With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975295
• Other study ID #: 17291
• Secondary ID: I9S-MC-BTAC2019-
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: December 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• LY3361237
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Bulgaria	MC Comac Medical	Sofia
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Poland	All Med - Lodz	Lodz
Poland	Ai Centrum Medyczne Sp. Z O.O. Sp.K.	Poznan
Poland	Pratia - Warsaw	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Slovakia	Summit Clinical Research, s.r.o. - Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval	PK: Cmin of LY3361237 During the Dosing Interval	Day 1 predose through Day 253

External Links

•   A Study of LY3361237 in Participants With Psoriasis