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

NCT05896527 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: DCE8062012022-502249-90-00J5B-MC-FHAG
• Study Type: interventional
• Target: 229
• Locations: 8 countries
• Sites: 56

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at 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.

  Week 12

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations

  * 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.

  Baseline through End of follow-up (Up to 16 weeks)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received placebo tablets orally twice daily (BID) for 12 weeks.

Other: Placebo

DC-806 200 mg BID

EXPERIMENTAL

Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.

Drug: DC-806

DC-806 400 mg BID

EXPERIMENTAL

Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.

Drug: DC-806

DC-806 600 mg QD

EXPERIMENTAL

Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.

Drug: DC-806

DC-806 800 mg BID

EXPERIMENTAL

Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.

Drug: DC-806

Interventions

DC-806 DRUG

DC-806 was supplied as tablets to be administered orally.

DC-806 200 mg BID; DC-806 400 mg BID; DC-806 600 mg QD; DC-806 800 mg BID

Placebo OTHER

Matching placebo was supplied as tablets to be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Systemic use of known strong and moderate 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

Sponsors & Collaborators

• DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company: lead

Study Sites (56)

First OC Dermatology

Fountain Valley, California, 92708-3701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404-2120, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134-3901, United States

Location

Kirsch Dermatology - Probity - PPDS

Naples, Florida, 34102-6538, United States

Location

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, 33713-8012, United States

Location

ForCare Clinical Research - CenExel FCR - PPDS

Tampa, Florida, 33613-1244, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168-2792, United States

Location

Dermatology Specialists Research - 501 S 2nd St

Louisville, Kentucky, 40202-2862, United States

Location

DICE Therapeutics Study Site

New York, New York, 10003-3314, United States

Location

Dermatologists of Southwest Ohio - Probity - PPDS

Mason, Ohio, 45040-4520, United States

Location

Paddington Testing Company Inc

Philadelphia, Pennsylvania, 19103-4738, United States

Location

Center for Clinical Studies - Webster

Webster, Texas, 77598-4927, United States

Location

Virginia Clinical Research Inc

Norfolk, Virginia, 23502-3945, United States

Location

Alberta DermaSurgery Centre - Probity - PPDS

Edmonton, Alberta, T6G 1C2, Canada

Location

Enverus Medical Research - Probity - PPDS

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research Inc. - Probity - PPDS

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

CCA Medical Research - Probity - PPDS

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS

Barrie, Ontario, L4M 7G1, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lynderm Research Inc. - Probity - PPDS

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research Probity - PPDS

Mississauga, Ontario, Canada

Location

DICE Therapeutics Study Site

North York, Ontario, M2M 4J5, Canada

Location

Alliance Clinical Trials - Probity - PPDS

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Québec, G1V 4X7, Canada

Location

Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS

Prague, Praha, Hlavní Mesto, 100 00, Czechia

Location

CCR Prague s.r.o. - PRATIA - PPDS

Prague, Praha, Hlavní Mesto, 130 00, Czechia

Location

CCR Prague s.r.o. - PRATIA - PPDS

Prague, 100 00, Czechia

Location

DICE Therapeutics Study Site

Prague, 150 00, Czechia

Location

DICE Therapeutics Study Site

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

DICE Therapeutics Study Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

DICE Therapeutics Study Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

DICE Therapeutics Study Site

Leipzig, Saxony, 4103, Germany

Location

DICE Therapeutics Study Site

Berlin, 10117, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

DICE Therapeutics Study Site

Lübeck, 23538, Germany

Location

DICE Therapeutics Study Site

Tübingen, 72076, Germany

Location

Allergo-Derm Bakos Kft.

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

DICE Therapeutics Study Site

Kaposvár, Somogy County, 7400, Hungary

Location

DICE Therapeutics Study Site

Szombathely, Vas County, 9700, Hungary

Location

Semmelweis Egyetem

Budapest, 1085, Hungary

Location

DICE Therapeutics Study Site

Gyöngyös, 3200, Hungary

Location

MedMare Bt

Veszprém, 8200, Hungary

Location

Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Wro Medica

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Dermoklinika-Centrum Medyczne s.c

Lódz, Lódzkie, 90-436, Poland

Location

Centrum Medyczne Reuma Park NZOZ

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

ClinicMed Daniluk, Nowak Spólka Komandytowa

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Laser Clinic S.C.

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28026, Spain

Location

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, 50009, Spain

Location

Synexus Merseyside Clinical Research Centre

Liverpool, Lancashire, L22 0LG, United Kingdom

Location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor, participants, Investigators, and study staff responsible for any study procedures was blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: May 2, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CZ (4); CA (11); ES (3); DE (9); HU (6); PL (8); GB (2)