DC-806 for Plaque Psoriasis

(Illuminate Trial)

Recruiting at 109 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

229 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral medication called DC-806. It targets people with moderate to severe plaque psoriasis. The study will check how well the medication works, its safety, and how the body processes it.

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.

What makes the drug DC-806 unique for treating plaque psoriasis?

The drug DC-806 is unique for treating plaque psoriasis because it is designed to target specific immune responses involved in the condition, potentially offering a more focused approach compared to traditional systemic immunosuppressive therapies, which can have significant long-term side effects. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clearing of psoriasis by a novel immunosuppressive macrolide. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Myeloid but not plasmacytoid blood DCs possess Th1 polarizing and Th1/Th17 recruiting capacity in psoriasis. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Early inflammatory changes in the "perilesional skin" of psoriatic plaques: is there interaction between dendritic cells and keratinocytes? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Increase in TNF-alpha and inducible nitric oxide synthase-expressing dendritic cells in psoriasis and reduction with efalizumab (anti-CD11a). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Epidermal dendritic cells in psoriasis possess a phenotype associated with antigen presentation: in situ expression of beta 2-integrins. [2019]