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

DICE Therapeutics

Status and phase: Completed; 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: 222 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

---

222 participants in 4 patient groups, including a placebo group

LY4100511 200 mg BID

Experimental group

Description:

Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.

Treatment:

Drug: LY4100511

LY4100511 400 mg BID

Experimental group

Description:

Participants received LY4100511 400 mg administered orally BID for 12 weeks.

Treatment:

Drug: LY4100511

LY4100511 800 mg QD

Experimental group

Description:

Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.

Treatment:

Drug: LY4100511

Placebo BID

Placebo Comparator group

Description:

Participants received placebo administered orally BID for 12 weeks.

Treatment:

Drug: Placebo