臨床研究等提出・公開システム

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants With Moderate-to Severe Plaque Psoriasis (J5C-MC-FOAB)

A Phase 2 Dose-Ranging Study of LY4100511 (Dice 853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (J5C-MC-FOAB)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Nov. 11, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
- Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
- Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
- Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study

- Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
- Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
- Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
- Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
- Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.

Both

Plaque Psoriasis

DRUG: LY4100511
Administered orally
DRUG: Placebo
Administered orally

[Study Arms]
Experimental: LY4100511 Dose 1
Participants will receive LY4100511 orally.
Interventions:
Drug: LY4100511
Experimental: LY4100511 Dose 2
Participants will receive LY4100511 orally.
Interventions:
Drug: LY4100511
Experimental: LY4100511 Dose 3
Participants will receive LY4100511 orally.
Interventions:
Drug: LY4100511
Placebo Comparator: Placebo
Placebo administered orally.
Interventions:
Drug: Placebo

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Week 12

+81-3-3881-6116

Sept. 27, 2024

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States