DC-806 for Plaque Psoriasis

(Illuminate Trial)

No longer recruiting at 117 trial locations

Overseen By DICE Therapeutics Clinical Trial Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: DICE Therapeutics, Inc.

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Chronic infections, Active tuberculosis, Malignancy, 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 tests a new oral medication, DC-806, to determine if it can safely and effectively treat moderate to severe plaque psoriasis, a skin condition causing red, scaly patches. Participants will receive varying doses of DC-806 or a placebo to identify the optimal dose and monitor for side effects. The trial seeks individuals who have had plaque psoriasis for at least six months and experience large affected skin areas. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

Yes, you will need to stop using topical and/or systemic therapies for psoriasis before starting the study drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DC-806 has undergone safety testing in several studies. These studies found that people generally tolerate DC-806 well. Participants did not report any severe side effects, and researchers administered the medication in different doses to ensure safety.

Some mild side effects occurred, but they were not serious enough to halt the treatment. This is encouraging for those considering joining the trial. Since DC-806 is in a Phase 2 study, it has already passed initial safety checks in earlier stages. This phase focuses more on the treatment's effectiveness, but safety remains closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

DC-806 is unique because it targets plaque psoriasis differently than most current treatments. While standard therapies like biologics and topical treatments often focus on controlling inflammation or suppressing the immune system broadly, DC-806 is designed to specifically inhibit a key protein involved in inflammation, potentially offering a more targeted approach. Researchers are excited about DC-806 as it could provide an effective oral treatment with fewer side effects compared to the broader immune suppression seen with some existing options. This specificity might lead to better management of psoriasis symptoms with improved patient comfort and convenience.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

Research shows that DC-806 holds promise for treating plaque psoriasis. Early results indicate that after 4 weeks of treatment, participants experienced an average reduction of 43.7% in the Psoriasis Area and Severity Index (PASI), which measures the severity and extent of psoriasis. Another study aimed for a 75% improvement in PASI scores after 12 weeks. This trial will test various dosages of DC-806 to evaluate its effectiveness in reducing psoriasis symptoms. These findings offer hope for those seeking new treatments for moderate to severe plaque psoriasis. ^{1 3 6 7 8}

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?

Adults aged 18-70 with moderate to severe plaque psoriasis, who have had it for at least 6 months and are candidates for phototherapy or systemic therapy. They must have a BMI of 18-40 kg/m2 and agree to use effective contraception. Exclusions include certain abnormal lab values, recent flares or infections, history of significant mental health issues, strong drug interactions, heart abnormalities, chronic infections like HIV/hepatitis/TB, cancer in the last 5 years (except some skin cancers), or no response to specific psoriasis treatments.

Inclusion Criteria

Body mass index (BMI) of 18 to 40 kg/m2

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

I am willing to use effective birth control during and for 30 days after the study.

Exclusion Criteria

I have a history of severe psoriasis worsened by medication.

My psoriasis has significantly worsened in the last 12 weeks.

I haven't had cancer or similar diseases in the last 5 years, except for treated skin cancer without return.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DC-806 or placebo tablets orally for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DC-806
• Placebo

Trial Overview The trial is testing DC-806's effectiveness and safety compared to a placebo over a period of 12 weeks. Participants will be randomly assigned to receive either multiple oral doses of DC-806 or a placebo in double-blind fashion (neither participants nor researchers know who receives which treatment). The study also looks into how the body processes the drug.

How Is the Trial Designed?

Group I: DC-806 800 mg BID Experimental Treatment 1 Intervention

Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.

Group II: DC-806 600 mg QD Experimental Treatment 1 Intervention

Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.

Group III: DC-806 400 mg BID Experimental Treatment 1 Intervention

Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.

Group IV: DC-806 200 mg BID Experimental Treatment 1 Intervention

Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.

Group V: Placebo Placebo Group 1 Intervention

Participants received placebo tablets orally twice daily (BID) for 12 weeks.

Who Is Running the Clinical Trial?

DICE Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

270+

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05896527

A Study to Evaluate the Efficacy and Safety of DC-806 in ... This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-dc-806-in-participants-with-moderate-to-severe-plaque

A Study to Evaluate the Efficacy and Safety of DC-806 in ... This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-dc-806-for-adults-with-moderate-to-severe-plaque-psoriasis/

Study on the Effectiveness and Safety of DC-806 for Adults ... This clinical trial investigates the efficacy and safety of DC-806, a film-coated tablet, in treating adults with moderate to severe plaque psoriasis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10892104/

New and Emerging Oral/Topical Small-Molecule ... The primary efficacy endpoint was 75% or more improvement in Psoriasis Area and Severity Index (PASI) with respect to baseline (PASI75 response) at 12 weeks.

5. agentcapital.com agentcapital.com/2022/10/dice-therapeutics-announces-positive-topline-data-from-phase-1-clinical-trial-of-lead-oral-il-17-antagonist-dc-806-for-psoriasis/

DICE Therapeutics Announces Positive Topline Data from ... Following 4 weeks of treatment, the mean percentage reduction in Psoriasis Area and Severity Index (PASI) from baseline was 43.7% in the high ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06808815

NCT06808815 | A Study to Assess S011806 (DC-806 or ... The main purpose of this study is to learn more about the safety and side effects of DC-806 when given by mouth to healthy participants and participants ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05896527/a-study-to-evaluate-the-efficacy-and-safety-of-dc-806-in-participants-with-moderate-to-severe-plaque-psoriasis

A Study to Evaluate the Efficacy and Safety of DC-806 in ... This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe ...

8. clinicaltrials.eu clinicaltrials.eu/inn/dc-806/

DC-806: A Promising New Drug for Plaque Psoriasis ... This medication is currently undergoing clinical trials to evaluate its effectiveness and safety. DC-806 is administered orally as tablets, making it ...