A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis

DICE Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: LY4100511

Study type: Interventional

Funder types: Industry

Identifiers

NCT06602219

18845

J5C-MC-FOAB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups, including a placebo group

LY4100511 Dose 1

Experimental group

Description:

Participants will receive LY4100511 orally.

Treatment:

Drug: LY4100511

LY4100511 Dose 2

Experimental group

Description:

Participants will receive LY4100511 orally.

Treatment:

Drug: LY4100511

LY4100511 Dose 3

Experimental group

Description:

Participants will receive LY4100511 orally.

Treatment:

Drug: LY4100511

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo