Ended Therapeutic exploratory (Phase II) Plaque Psoriasis

A Phase 2, Dose-Ranging Study of LY4100511 (DC-853) in Adult Participants with Moderate-to-Severe Plaque Psoriasis

EU CTIS ID: 2024-512207-39-00

What this study is testing

To compare the efficacy of multiple dose regimens of LY4100511 versus placebo in adult participants with moderate-to-severe plaque psoriasis

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participants are eligible to be included in this study only if all of the following criteria apply: Age 1. Must be 18 to 70 years of age, inclusive, at the time of signing the informed consent. Type of participant and disease characteristics 2. Must meet all of the following psoriasis criteria: • clinical diagnosis of plaque psoriasis for >/= 6 months before the baseline visit (Day 1/randomization) • stable moderate to severe plaque psoriasis, defined as >/= 10% BSA psoriasis involvement, sPGA score of >/=3, and PASI score >/=12 at the screening and baseline visits, and • candidate for phototherapy or systemic therapy, as assessed by the investigator. Weight 3. Must have a BMI of 18 to 40 kg/m2 (inclusive). Sex assigned at birth and contraceptive/barrier requirements 4. Individuals AMAB or AFAB, IOCBP or INOCBP, may participate in this trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For the contraception requirements of this protocol Informed consent 5. Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Other inclusion criteria 6. Are able to swallow oral medication. 7. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 8. Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention. 9. 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.

You likely can't join if

  • Participants are excluded from the study if any of the following criteria apply: -Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline visit -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, or systemic lupus erythematosus -Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment -Have any active skin disease other than psoriasis that could interfere with the assessment of psoriasis -Have a current or recent acute, active infection -Have had any of the following types of infection within 3 months prior to the screening visit or develops any of these infections before the randomization visit: •Serious (requiring hospitalization or intravenous or equivalent oral antibiotic treatment) •Opportunistic (Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over) •Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer) •Recurring (including, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis) •Have active TB •Have or have had LTBI that has not been treated with a complete course of appropriate therapy, unless such treatment is underway •Have a current infection with HBV or HCV •Have HIV infection -Have a history of malignancy or lymphoproliferative disease -Have previously received a solid organ transplant -Have undergone major surgery within 12 weeks before the first dose of study intervention or such surgery is planned to be performed during the study •Have History or evidence of hepatic impairment, any current serious or unstable illnesses including renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions, have history of significant allergies to lidocaine or other topical anesthetics -Are actively suicidal and therefore deemed to be at significant risk for suicide -History of a suicide attempt within the 5 years prior to the Screening Visit. -Have answered “yes” to either Question 4 or Question 5 on the “Suicidal Ideation” portion of the C-SSRS and the ideation occurred within the past month OR Have answered “yes” to any of the suicide-related behaviors on the “suicidal behavior” portion of the C-SSRS and the behavior occurred within the past 3 months -Have received any live vaccine within the 6 weeks before the first dose of study intervention, a BCG vaccination or treatment within less than 4 weeks before randomization, or intend to receive BCG vaccination or treatment during the study -Have received any therapeutic agent targeting IL-17 and discontinued the anti IL-17 therapy for any of the following reasons: did not how addecuate response after treatment of at least 3 months and/or lost response after prolonged therapy, intolerability or toxicity, irrespective of treatment duration -Have received any therapeutic agent targeting IL-17within 16 weeks or 5 laf lives before the first dose of study intervention - Have received anti-TNFα inhibitor(s) or agents that modulate B cells or T cells within 12 weeks or 5 half-lives before the first dose of study intervention For other exclusion criteria refer to the Protocol

The study team makes the final eligibility decision.

Where it's taking place

  • Japan
  • Canada
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Japan; Canada; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.