Trial intelligence / Profile preview

LY4100511 in Moderate-to-Severe Plaque Psoriasis

NCT06602219Phase 2

Key facts

Status
Completed
Start
Oct 2024
Primary completion
Jul 2025
Countries
7
Conditions
plaque psoriasis
01

Overview

Phase 2, randomised, double-blind trial of simepdekinra in plaque psoriasis (4 arms), sponsored by DICE Therapeutics. Primary endpoint: Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index at 12 weeks. Started Oct 2024; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • LY4100511 200 mg BID

    LY4100511 200 mg administered orally twice daily for 12 weeks.

  • LY4100511 400 mg BID

    LY4100511 400 mg administered orally twice daily for 12 weeks.

  • LY4100511 800 mg QD

    LY4100511 800 mg administered orally once daily for 12 weeks, with matching placebo in the evening.

  • Placebo BID

    Placebo administered orally twice daily for 12 weeks.

03

Who it enrols

Adults with moderate-to-severe plaque psoriasis for at least 6 months, BMI 18-40 kg/m2, willing to discontinue other psoriasis therapies, no recent significant flare, no other inflammatory conditions or active infections.

04

Endpoints

Primary

  • Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index

Secondary

  • Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement

  • Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index

  • Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index

  • Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index

  • Change From Baseline in PASI Score

  • Percent Change From Baseline in PASI Score

  • Change From Baseline in the Percentage of Body Surface Area Affected

  • Percent Change From Baseline in the Percentage of BSA Affected

Beyond the preview

Go deeper on NCT06602219.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT06602219.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call