Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as S011806, LY4100504
DC-806 · 2 trials · 1 indication
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.
* 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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets orally twice daily (BID) for 12 weeks. |
| DC-806 200 mg BID | EXPERIMENTAL | Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks. |
| DC-806 400 mg BID | EXPERIMENTAL | Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks. |
| DC-806 600 mg QD | EXPERIMENTAL | Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks. |
| DC-806 800 mg BID | EXPERIMENTAL | Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks. |
| Part 1: DC-806 | EXPERIMENTAL | Single ascending dose of DC-806 administered orally. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Placebo administered orally. |
| Part 2: DC-806 | EXPERIMENTAL | Multiple ascending doses of DC-806 administered orally. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Placebo administered orally |
| Part 3:DC-806 | EXPERIMENTAL | DC-806 administered orally |
| Part 3: Placebo | PLACEBO_COMPARATOR | Placebo administered orally |
| Name | Type | Description |
|---|---|---|
| DC-806 | DRUG | DC-806 was supplied as tablets to be administered orally. |
| Placebo | OTHER | Matching placebo was supplied as tablets to be administered orally. |
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...
DC-806 is an investigational small molecule being developed for the treatment of plaque psoriasis, a chronic inflammatory skin condition. It is being studied in adults with moderate to severe plaque psoriasis as well as in healthy adult participants. It has not been approved for any indication and remains in clinical development.
DC-806 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the drug in plaque psoriasis.
DC-806 has completed a Phase 2 clinical trial in moderate to severe plaque psoriasis. The program also includes a completed Phase 1 study. DC-806 is investigational and has not been approved by the FDA or any other regulatory authority for the treatment of plaque psoriasis.
DC-806 has been evaluated in two completed trials. NCT05896527 was a Phase 2 study of 229 participants with moderate to severe plaque psoriasis conducted across the United States, Canada, Czechia, Germany, Hungary, Poland, Spain, and the United Kingdom. NCT06808815 was a Phase 1 study of 104 healthy adults and participants with chronic plaque psoriasis in the United Kingdom.
Yes. DC-806 is also known as LY4100504 and has been referred to as S011806 in trial documentation. These names identify the same investigational small molecule developed by Eli Lilly and Company for plaque psoriasis.
The Phase 2 trial NCT05896527 was a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of DC-806 in 229 adults with moderate to severe plaque psoriasis. Participants were at least 18 years of age, and the study has been completed.