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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dice Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

30 Jan 2025 → 4 Sep 2025

Decision date (initial)

2025-01-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

External identifiers

EU CT number

2024-512207-39-00

ClinicalTrials.gov

NCT06602219

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacokinetic, Safety

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

Secondary objectives 3

1. 1. To compare the efficacy of various LY4100511 dose regimens in adult participants with moderate-to-severe plaque psoriasis
2. 2. To compare the safety and tolerability of multiple dose regimens of LY4100511 versus placebo in adult participants with moderate-to-severe plaque psoriasis
3. 3. To assess the PK of LY4100511 in adult participants with moderate-to-severe plaque psoriasis

Conditions and MedDRA coding

Plaque Psoriasis

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving PASI 75 at Week 12

Secondary endpoints 3

1. 1. Proportion of participants achieving: • an sPGA score of 0 or 1 with ≥2 grade improvement from baseline at Week 12 • ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score at all scheduled timepoints • an sPGA score of 0 or 1 at all scheduled timepoints • Mean change and percent change from baseline in PASI score at all scheduled timepoints • Mean change and percent change from baseline in the percentage of BSA affected at all scheduled timepoints
2. 2. Summary of safety data, including number and proportion of: • TEAEs • SAEs • discontinuations due to TEAEs
3. 3. Measurement of plasma concentration of LY4100511 at scheduled timepoints to evaluate steady state maximum concentration (Cmax,ss) and trough concentration (Ctrough,ss) and associated intra-individual variability

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dice Therapeutics Inc.

Sponsor organisation

Dice Therapeutics Inc.

Address

400 East Jamie Court Suite 300

City

South San Francisco

Postcode

94080-6230

Country

United States

Scientific contact point

Organisation

Dice Therapeutics Inc.

Contact name

Jeffrey Enejosa, MD

Public contact point

Organisation

Dice Therapeutics Inc.

Contact name

Vandana Nathan

Third parties 8

Locations

4 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications