Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DC-806 · 5 trials · 3 indications
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. |
| Cohort 1: DC-806 + Midazolam (CYP3A4 substrate) + Repaglinide (CYP2C8 substrate) | EXPERIMENTAL | Participants will receive a single oral dose of the 2-probe substrate cocktail (midazolam and repaglinide) on Day 1. From Day 4 through Day 8, participants will receive twice-daily (BID) oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 7. DC-806 BID dosing will continue until the end of Day 8. |
| Cohort 2: DC-806 + Digoxin (P-gp substrate) + Rosuvastatin (BCRP/OATP1B1 substrate) | EXPERIMENTAL | Participants will receive a single oral dose of the 2-probe substrate cocktail (digoxin and rosuvastatin) on Day 1. From Day 5 through Day 9, participants will receive twice daily oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 8. DC-806 BID dosing will continue until the end of Day 9. |
| [14C]-DC-806 | EXPERIMENTAL | Participants will receive a single oral dose of unlabeled DC-806 tablets followed by DC-806 capsule containing 3.7 MBq (100 μCi) of \[14C\]-DC-806 on Day 1. |
| Cohort 1 | EXPERIMENTAL | Participants in Cohort 1 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with itraconazole after the wash-out period. |
| Cohort 2 | EXPERIMENTAL | Participants in Cohort 2 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with carbamazepine after the wash-out period. |
| 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. |
| Midazolam | DRUG | Oral syrup |
| Repaglinide | DRUG | Oral tablets |
| Digoxin | DRUG | Oral tablets |
| Rosuvastatin | DRUG | Oral tablets |
| [14C]-DC-806 | DRUG | Oral capsules |
| Itraconazole | DRUG | Oral capsules |
| Carbamazepine | DRUG | Oral tablets |
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 studied for the treatment of plaque psoriasis. It has been evaluated in clinical trials involving participants with moderate to severe plaque psoriasis, as well as in healthy volunteers for pharmacokinetic studies. The drug is being developed by Eli Lilly and Company.
DC-806 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker LLY. The drug is an investigational small molecule that has been studied in clinical trials for plaque psoriasis and in healthy volunteer studies.
DC-806 has been studied in Phase 1 and Phase 2 clinical trials. While the drug has completed trials, it remains investigational and has not been approved by regulatory authorities. The development program includes studies in healthy volunteers and in participants with plaque psoriasis.
DC-806 has been evaluated in several completed clinical trials, including NCT05896527, a Phase 2 study in moderate to severe plaque psoriasis; NCT05994807, a drug-drug interaction study; NCT06045000, a mass balance study; and NCT06808815, a study in healthy adults and participants with chronic plaque psoriasis.
Yes, DC-806 is also known as S011806 and LY4100504. A clinical trial (NCT06808815) assessed S011806, which is identified as DC-806 or LY4100504, in healthy adult participants and participants with chronic plaque psoriasis.