A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- DC-806
- Conditions
- Plaque Psoriasis
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Enrollment
- 229
- Locations
- 43
- Primary Endpoint
- Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This was a 12-week treatment, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.
Investigators
Eligibility Criteria
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 ≥10% BSA psoriasis involvement, sPGA score of ≥3, and PASI score ≥12 at the Screening and Baseline visits
- •Candidate for phototherapy or systemic therapy, as assessed by the Investigator
- •Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use a highly effective method of contraception during the study and for ≥30 days after the last dose of study drug
- •Willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study drug
Exclusion Criteria
- •Have had a clinically significant flare of psoriasis during the 12 weeks before the Baseline visit, as assessed by the Investigator
- •History of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, medication-induced or medication-exacerbated psoriasis
- •History of chronic infections including human immunodeficiency virus (HIV) or viral hepatitis (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\])
- •History of active tuberculosis (TB)
- •History or evidence of active infection (including but not limited to coronavirus disease 2019 \[COVID-19\] infection) and/or febrile illness within 7 days, serious infections leading to hospitalization and intravenous antibiotic treatment within 90 days, or serious infection requiring antibiotic treatment within 30 days before the first dose of study drug
- •History of malignancy or lymphoproliferative disease except resected cutaneous squamous cell or basal cell carcinoma that has been treated without recurrence
- •Presence of active suicidal ideation, or positive suicide behavior using the "Baseline/Screening" version of the Columbia Suicide Severity Rating Scale (C-SSRS) and with either of the following criteria:
- •History of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) within 5 years before the Screening visit
- •Suicidal ideation in the past month before the Screening visit as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Baseline/Screening" version of the C-SSRS
- •Participant has experienced primary failure (no response at approved doses after ≥3 months of therapy) to one or more therapeutic agents targeted to IL-17 (including but not limited to secukinumab, ixekizumab, brodalumab, bimekizumab)
Arms & Interventions
DC-806 400 mg BID
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
Intervention: DC-806
Placebo
Participants received placebo tablets orally twice daily (BID) for 12 weeks.
Intervention: Placebo
DC-806 200 mg BID
Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
Intervention: DC-806
DC-806 600 mg QD
Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
Intervention: DC-806
DC-806 800 mg BID
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
Intervention: DC-806
Outcomes
Primary Outcomes
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Time Frame: 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
Time Frame: 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.