LY4100511 for Psoriasis

No longer recruiting at 74 trial locations

Overseen By There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Corticosteroids, Immunosuppressants, Biologics

Disqualifiers: Psoriatic arthritis, Inflammatory conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment, LY4100511, for individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. Participants will join one of several groups to receive either different doses of LY4100511 (also known as DC-853) or a placebo (a pill with no active drug). The trial seeks adults who have had plaque psoriasis for at least six months and are willing to stop other psoriasis treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you must stop using topical and/or systemic therapies for psoriasis before starting the study treatment.

Is there any evidence suggesting that LY4100511 is likely to be safe for humans?

Research shows that LY4100511 is being tested for safety and effectiveness in treating moderate-to-severe plaque psoriasis. Earlier studies have assessed how well people tolerate this treatment. LY4100511 has been tested on both healthy individuals and those with specific conditions. Although detailed safety results from these studies aren't available yet, its progression to the current phase suggests some level of safety. In this phase, researchers focus on ensuring the treatment's safety for participants. As with any clinical trial, side effects may occur, but ongoing research aims to understand and manage these risks better. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Unlike current treatments for psoriasis, which often involve topical steroids or biologics targeting specific immune pathways, LY4100511 is taken orally and may offer a novel approach to managing the condition. Researchers are excited because LY4100511 potentially targets different aspects of the immune response, which might lead to improved efficacy or fewer side effects. Additionally, having an oral treatment could provide a more convenient option for patients compared to injections or topical applications.

What evidence suggests that LY4100511 might be an effective treatment for psoriasis?

Research is investigating LY4100511 as a potential treatment for moderate-to-severe plaque psoriasis. Early studies have shown that similar treatments have greatly benefited individuals with severe psoriasis. In this trial, participants will receive one of three different doses of LY4100511 or a placebo to assess its safety and effectiveness when taken orally. While data on this specific treatment remains limited, it builds on promising results from similar therapies. This offers hope that LY4100511 could reduce psoriasis symptoms in future patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe plaque psoriasis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

I agree to avoid sun exposure and not use tanning devices during the study.

Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive)

I have been diagnosed with plaque psoriasis for at least 6 months.

Exclusion Criteria

I am being treated with drugs that affect my immune system for psoriatic arthritis.

I have a history of severe psoriasis.

I have a condition like psoriasis or psoriatic arthritis, but not conditions like rheumatoid arthritis or lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4100511 or placebo orally for the treatment of moderate-to-severe plaque psoriasis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4100511

Trial Overview The study is testing the safety and effectiveness of a new medication called LY4100511 compared to a placebo in treating plaque psoriasis. This phase 2 trial will help determine the appropriate dose range for future studies.

How Is the Trial Designed?

Group I: LY4100511 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY4100511 orally.

Group II: LY4100511 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY4100511 orally.

Group III: LY4100511 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY4100511 orally.

Group IV: Placebo Placebo Group 1 Intervention

Placebo administered orally.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

10

Recruited

810+

Published Research Related to This Trial

In a study using slc15a4feeble mice, which have unresponsive plasmacytoid dendritic cells (pDC), treatment with the TLR7-agonist imiquimod (IMQ) resulted in significantly reduced skin thickening compared to wildtype mice, indicating that pDC play a crucial role in the inflammatory response in psoriasis.

The absence of slc15a4 led to a marked reduction in systemic IFN-I induction and a blunted inflammatory response, suggesting that targeting pDC function could be a potential therapeutic strategy for managing psoriasis-related inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A requirement for slc15a4 in imiquimod-induced systemic inflammation and psoriasiform inflammation in mice. Griffith, AD., Zaidi, AK., Pietro, A., et al.[2019]

In a study involving 15 patients with severe psoriasis, the topical application of the macrolide SDZ 281-240 resulted in significant improvement of psoriatic lesions within 10 days, demonstrating its potential as an effective local treatment.

Biopsies confirmed that SDZ 281-240 reversed the histopathological and immunopathological features of psoriasis, indicating that it effectively suppresses the underlying immune response without affecting keratinocyte proliferation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clearing of psoriasis by a novel immunosuppressive macrolide. Rappersberger, K., Meingassner, JG., Fialla, R., et al.[2019]

The study identified a significant increase of FLT3(+) CD11c(+) dendritic cells in psoriatic lesions, suggesting their role in psoriasis pathology and highlighting a potential target for treatment.

The FLT3 inhibitor SKLB4771 effectively treated psoriasis-like symptoms in mice, almost completely curing the condition without noticeable toxicity, indicating a promising new therapeutic strategy that targets dendritic cells rather than T cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accumulation of FLT3(+) CD11c (+) dendritic cells in psoriatic lesions and the anti-psoriatic effect of a selective FLT3 inhibitor. Yan, HX., Li, WW., Zhang, Y., et al.[2021]

FXYD3 is significantly increased in the skin of psoriasis patients and contributes to the disease by enhancing IL-17A signaling in keratinocytes, which promotes inflammation and skin lesions.

Deleting FXYD3 in keratinocytes reduced psoriasis-like symptoms in a mouse model, suggesting that targeting FXYD3 could be a promising therapeutic strategy for treating psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FXYD3 enhances IL-17A signaling to promote psoriasis by competitively binding TRAF3 in keratinocytes. Yang, W., He, R., Qu, H., et al.[2023]

In a mouse model of psoriasis, the Notch1/Hes1-PTEN/AKT/IL-17A feedback loop was found to regulate Th17 cell differentiation, which is crucial for the development of psoriasis.

Treatment with the PI3K/AKT inhibitor LY294002 significantly reduced psoriasis-like skin inflammation and reversed the increased Th17 cell activity, suggesting that targeting this feedback loop could be a promising therapeutic strategy for managing psoriatic inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notch1/Hes1‑PTEN/AKT/IL‑17A feedback loop regulates Th17 cell differentiation in mouse psoriasis‑like skin inflammation. Lin, YW., Li, XX., Fu, FH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06602219

NCT06602219 | A Study of LY4100511 (DC-853) in Adult ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

2. trials.lilly.com trials.lilly.com/en-US/trial/533216

A Study of LY4100511 (DC-853) in Adult Participants With ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

3. clinicaltrials.eu clinicaltrials.eu/inn/ly4100511/

Ly4100511 – Application in Therapy and Current Clinical ... These studies aim to evaluate its safety, tolerability, and effectiveness in healthy individuals and patients with specific conditions like plaque psoriasis.

4. withpower.com withpower.com/trial/phase-2-psoriasis-vulgaris-plaque-psoriasis-9-2024-1efbd

LY4100511 for Psoriasis · Info for Participants In a study involving 15 patients with severe psoriasis, the topical application of the macrolide SDZ 281-240 resulted in significant improvement of psoriatic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11313207/

New and emerging oral therapies for psoriasis - PMC This narrative review synthesizes the emerging oral therapeutic agents for psoriasis, focusing on their mechanisms of action, stages of development and clinical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06602219

NCT06602219 | A Study of LY4100511 (DC-853) in Adult ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis. Official ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=30b206ad-83d7-45dc-8e97-75fe562df7e1

simepdekinra (LY4100511) / Eli Lilly A study to evaluate safety, tolerability of LY4100511 (DC-853) in healthy Asian and non-Asian participants.