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DC-806

Phase 2

Plaque Psoriasis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Apr 4, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment333
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05896527A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque PsoriasisPHASE2 COMPLETED 229May 2, 2023Mar 25, 2024Apr 4, 202556 United States, Canada +6
NCT06808815A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque PsoriasisPHASE1 COMPLETED 104Sep 22, 2021Aug 23, 2022Feb 5, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Week 12

Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations
Baseline through End of follow-up (Up to 16 weeks)

* A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug. * An SAE is any untoward medical occurrence that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.

Part 1: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Baseline Up To 7 Weeks

A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

Part 2: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Baseline Up To 7 Weeks

A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

Part 3: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Baseline Up To 11 Weeks

A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

Secondary Endpoints
Part 1, Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of DC-806.
Pre-dose up-to 48 hours post-dose
Part 1, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806.
Pre-dose up-to 48 hours post-dose
Part 1, PK: Time to reach maximum observed (Tmax) of DC-806
Pre-dose up-to 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received placebo tablets orally twice daily (BID) for 12 weeks.
DC-806 200 mg BIDEXPERIMENTALParticipants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
DC-806 400 mg BIDEXPERIMENTALParticipants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
DC-806 600 mg QDEXPERIMENTALParticipants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
DC-806 800 mg BIDEXPERIMENTALParticipants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
Part 1: DC-806EXPERIMENTALSingle ascending dose of DC-806 administered orally.
Part 1: PlaceboPLACEBO_COMPARATORPlacebo administered orally.
Part 2: DC-806EXPERIMENTALMultiple ascending doses of DC-806 administered orally.
Part 2: PlaceboPLACEBO_COMPARATORPlacebo administered orally
Part 3:DC-806EXPERIMENTALDC-806 administered orally
Part 3: PlaceboPLACEBO_COMPARATORPlacebo administered orally
Interventions
NameTypeDescription
DC-806DRUGDC-806 was supplied as tablets to be administered orally.
PlaceboOTHERMatching placebo was supplied as tablets to be administered orally.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites56

Key Inclusion Criteria: * Male or female, 18 to 70 years of age * Body mass index (BMI) of 18 to 40 kg/m2 * All of the following psoriasis criteria: * Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit * Stable moderate to severe chronic plaque psoriasis, defined as...

Countries:United StatesCanadaCzechiaGermanyHungaryPolandSpainUnited Kingdom
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