Illuminate: A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis

• Sponsor: DICE Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05896527
• Collaborator: (none)
• Enrollment: 225
• Locations: 63
• Arms: 5
• Anticipated Duration (Months): 15.4
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a 12-week, 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 will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: DC-806; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: The Sponsor, participants, Investigators, and study staff responsible for any study procedures will be blinded.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 11, 2023
• Anticipated Primary Completion Date: Jul 24, 2024
• Anticipated Study Completion Date: Aug 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1: DC-806 Dose A	Drug: DC-806; DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 2: DC-806 Dose B	Drug: DC-806; DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 3: DC-806 Dose C	Drug: DC-806; DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 4: DC-806 Dose D	Drug: DC-806; DC-806 will be supplied as tablets to be administered orally.
Placebo Comparator: Treatment Group 5: Placebo	Other: Placebo; Matching placebo will be supplied as tablets to be administered orally.

Outcome Measures

Primary Outcome Measures

1. Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75) [Week 12]

2. Incidence of treatment-emergent adverse events (TEAEs) [16 weeks]

3. Incidence of serious adverse events (SAEs) [20 weeks]

4. Incidence of TEAEs leading to discontinuation [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ≥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

Key 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 within the last 5 years 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)

• Systemic use of known strong cytochrome P450 (CYP)3A4 inhibitors or strong CYP3A4 inducers from Screening through the end of the study

• A 12-lead electrocardiogram (ECG) at Screening that demonstrates clinically significant abnormalities or criteria associated with QT interval abnormalities including prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) (>500 msec)

• Laboratory values meeting the following criteria within the screening period before the first dose of study drug:

• Serum aspartate transaminase ≥2× upper limit of normal (ULN)

• Serum alanine transaminase ≥2×ULN

• Serum total, direct, or indirect bilirubin ≥2.0 mg/dL; except for participants with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome

• Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula <45 mL/min/1.73m2

• Total white blood cell count <3000/μL

• Absolute neutrophil count <1500/μL

• Platelet count <100,000/μL

• Hemoglobin <9 g/dL

• In the opinion of the Investigator or Sponsor, have any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the participant's enrollment in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DICE Therapeutics Study Site	Rogers	Arkansas	United States	72758
2	DICE Therapeutics Study Site	Fountain Valley	California	United States	92708-3701
3	DICE Therapeutics Study Site	San Francisco	California	United States	94132-1910
4	DICE Therapeutics Study Site	Santa Monica	California	United States	90404-2120
5	DICE Therapeutics Study Site	Coral Gables	Florida	United States	33134-3901
6	DICE Therapeutics Study Site	Naples	Florida	United States	34102-6538
7	DICE Therapeutics Study Site	Saint Petersburg	Florida	United States	33713-8012
8	DICE Therapeutics Study Site	Tampa	Florida	United States	33613-1244
9	DICE Therapeutics Study Site	Indianapolis	Indiana	United States	46250-2041
10	DICE Therapeutics Study Site	Plainfield	Indiana	United States	46168-2792
11	DICE Therapeutics Study Site	Louisville	Kentucky	United States	40202-2862
12	DICE Therapeutics Study Site	Portsmouth	New Hampshire	United States	03801-7156
13	DICE Therapeutics Study Site	New York	New York	United States	10003-3314
14	DICE Therapeutics Study Site	Mason	Ohio	United States	45040-4520
15	DICE Therapeutics Study Site	Philadelphia	Pennsylvania	United States	19103-4738
16	DICE Therapeutics Study Site	Webster	Texas	United States	77598-4927
17	DICE Therapeutics Study Site	Norfolk	Virginia	United States	23502-3945
18	DICE Therapeutics Study Site	Calgary	Alberta	Canada	T2G 1B1
19	DICE Therapeutics Study Site	Edmonton	Alberta	Canada	T6G 1C2
20	DICE Therapeutics Study Site	Surrey	British Columbia	Canada	V3V 0C6
21	DICE Therapeutics Study Site	Winnipeg	Manitoba	Canada	R3M 3Z4
22	DICE Therapeutics Study Site	Ajax	Ontario	Canada	L1S 7K8
23	DICE Therapeutics Study Site	Barrie	Ontario	Canada	L4M 7G1
24	DICE Therapeutics Study Site	Hamilton	Ontario	Canada	L8N 1Y2
25	DICE Therapeutics Study Site	Markham	Ontario	Canada	L3P 1X2
26	DICE Therapeutics Study Site	North York	Ontario	Canada	M2M 4J5
27	DICE Therapeutics Study Site	Waterloo	Ontario	Canada	N2J 1C4
28	DICE Therapeutics Study Site	Quebec		Canada	G1V 4X7
29	DICE Therapeutics Study Site	Praha	Praha, Hlavní Mesto	Czechia	100 00
30	DICE Therapeutics Study Site	Praha	Praha, Hlavní Mesto	Czechia	130 00
31	DICE Therapeutics Study Site	Praha 10		Czechia	100 00
32	DICE Therapeutics Study Site	Praha 5		Czechia	150 00
33	DICE Therapeutics Study Site	Erlangen	Bayern	Germany	91054
34	DICE Therapeutics Study Site	Frankfurt am Main	Hessen	Germany	60590
35	DICE Therapeutics Study Site	Bonn	Nordrhein-Westfalen	Germany	53127
36	DICE Therapeutics Study Site	Münster	Nordrhein-Westfalen	Germany	48149
37	DICE Therapeutics Study Site	Dresden	Sachsen	Germany	1307
38	DICE Therapeutics Study Site	Leipzig	Sachsen	Germany	4103
39	DICE Therapeutics Study Site	Berlin		Germany	10117
40	DICE Therapeutics Study Site	Berlin		Germany	10789
41	DICE Therapeutics Study Site	Lübeck		Germany	23538
42	DICE Therapeutics Study Site	Tübingen		Germany	72076
43	DICE Therapeutics Study Site	Szolnok	Jász-Nagykun-Szolnok	Hungary	5000
44	DICE Therapeutics Study Site	Kaposvár	Somogy	Hungary	7400
45	DICE Therapeutics Study Site	Szombathely	Vas	Hungary	9700
46	DICE Therapeutics Study Site	Budapest		Hungary	1085
47	DICE Therapeutics Study Site	Gyöngyös		Hungary	3200
48	DICE Therapeutics Study Site	Veszprém		Hungary	8200
49	DICE Therapeutics Study Site	Wroclaw	Dolnoslaskie	Poland	50-566
50	DICE Therapeutics Study Site	Wroclaw	Dolnoslaskie	Poland	51-685
51	DICE Therapeutics Study Site	Lódz	Lódzkie	Poland	90-436
52	DICE Therapeutics Study Site	Warszawa	Mazowieckie	Poland	02-665
53	DICE Therapeutics Study Site	Rzeszów	Podkarpackie	Poland	35-055
54	DICE Therapeutics Study Site	Bialystok	Podlaskie	Poland	15-879
55	DICE Therapeutics Study Site	Katowice	Slaskie	Poland	40-611
56	DICE Therapeutics Study Site	Szczecin	Zachodniopomorskie	Poland	70-332
57	DICE Therapeutics Study Site	Barcelona		Spain	8041
58	DICE Therapeutics Study Site	Las Palmas De Gran Canaria		Spain	35010
59	DICE Therapeutics Study Site	Madrid		Spain	28026
60	DICE Therapeutics Study Site	Santiago De Compostela		Spain	50009
61	DICE Therapeutics Study Site	Chorley	Lancashire	United Kingdom	PR7 7NA
62	DICE Therapeutics Study Site	Liverpool	Lancashire	United Kingdom	L22 0LG
63	DICE Therapeutics Study Site	Manchester		United Kingdom	M23 9QZ

Sponsors and Collaborators

• DICE Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DICE Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05896527
• Other Study ID Numbers: DCE806201; 2022-502249-90-00
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Jun 9, 2023