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OpenTrials
Completed

NCT Number: NCT04975295

A Study of LY3361237 in Participants With Psoriasis

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MC Comac Medical, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3361237

Drug

Administered SC

Placebo

Drug

Administered SC

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

    Time frame: Baseline through Day 253

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

Secondary outcomes

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

    Time frame: Day 1 predose through Day 253

    PK: Cmin of LY3361237 During the Dosing Interval

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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