Plaque PsoriasisPhase 2IlluminateNCT05896527
A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing DC-806 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 56 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DC-806
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 56 sitesin 8 countries
- Study dates
- 2 May 2023to 25 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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
Trial locations and contacts
56 sites in 8 countries.
56 sites in 8 countries
United States13 sites
Driven Research LLC
Coral Gables, Florida, 33134-3901
First OC Dermatology
Fountain Valley, California, 92708-3701
Dermatology Specialists Research - 501 S 2nd St
Louisville, Kentucky, 40202-2862
Dermatologists of Southwest Ohio - Probity - PPDS
Mason, Ohio, 45040-4520
Kirsch Dermatology - Probity - PPDS
Naples, Florida, 34102-6538
DICE Therapeutics Study Site
New York, New York, 10003-3314
Virginia Clinical Research Inc
Norfolk, Virginia, 23502-3945
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103-4738
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168-2792
Clinical Science Institute
Santa Monica, California, 90404-2120
GCP Global Clinical Professionals, LLC
St. Petersburg, Florida, 33713-8012
ForCare Clinical Research - CenExel FCR - PPDS
Tampa, Florida, 33613-1244
Center for Clinical Studies - Webster
Webster, Texas, 77598-4927
Canada11 sites
CCA Medical Research - Probity - PPDS
Ajax, Ontario, L1S 7K8
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie, Ontario, L4M 7G1
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, T6G 1C2
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
Lynderm Research Inc. - Probity - PPDS
Markham, Ontario, L3P 1X2
DermEdge Research Probity - PPDS
Mississauga, Ontario
DICE Therapeutics Study Site
North York, Ontario, M2M 4J5
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, G1V 4X7
Enverus Medical Research - Probity - PPDS
Surrey, British Columbia, V3V 0C6
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, R3M 3Z4
Germany9 sites
DICE Therapeutics Study Site
Berlin, 10117
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
DICE Therapeutics Study Site
Bonn, North Rhine-Westphalia, 53127
DICE Therapeutics Study Site
Erlangen, Bavaria, 91054
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
DICE Therapeutics Study Site
Leipzig, Saxony, 4103
DICE Therapeutics Study Site
Lübeck, 23538
DICE Therapeutics Study Site
Münster, North Rhine-Westphalia, 48149
DICE Therapeutics Study Site
Tübingen, 72076
Poland8 sites
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok, Podlaskie Voivodeship, 15-879
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Dermoklinika-Centrum Medyczne s.c
Lódz, Lódzkie, 90-436
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, 35-055
Laser Clinic S.C.
Szczecin, West Pomeranian Voivodeship, 70-332
Centrum Medyczne Reuma Park NZOZ
Warsaw, Masovian Voivodeship, 02-665
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Lower Silesian Voivodeship, 50-566
Wro Medica
Wroclaw, Lower Silesian Voivodeship, 51-685
Hungary6 sites
Semmelweis Egyetem
Budapest, 1085
DICE Therapeutics Study Site
Gyöngyös, 3200
DICE Therapeutics Study Site
Kaposvár, Somogy County, 7400
Allergo-Derm Bakos Kft.
Szolnok, Jász-Nagykun-Szolnok, 5000
DICE Therapeutics Study Site
Szombathely, Vas County, 9700
MedMare Bt
Veszprém, 8200
Czechia4 sites
Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
Prague, Praha, Hlavní Mesto, 100 00
CCR Prague s.r.o. - PRATIA - PPDS
Prague, Praha, Hlavní Mesto, 130 00
CCR Prague s.r.o. - PRATIA - PPDS
Prague, 100 00
DICE Therapeutics Study Site
Prague, 150 00
Spain3 sites
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010
Hospital Universitario 12 de Octubre
Madrid, 28026
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, 50009
United Kingdom2 sites
Synexus Merseyside Clinical Research Centre
Liverpool, Lancashire, L22 0LG
Medicines Evaluation Unit
Manchester, M23 9QZ
About this study
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
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
- Being tested
- DC-806, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-806Drug
DC-806 was supplied as tablets to be administered orally.
PlaceboOther
Matching placebo was supplied as tablets to be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo tablets orally twice daily (BID) for 12 weeks. Receives: Other: Placebo |
| DC-806 200 mg BID | Experimental | Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks. Receives: Drug: DC-806 |
| DC-806 400 mg BID | Experimental | Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks. Receives: Drug: DC-806 |
| DC-806 600 mg QD | Experimental | Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks. Receives: Drug: DC-806 |
| DC-806 800 mg BID | Experimental | Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks. Receives: Drug: DC-806 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through End of follow-up (Up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start2 May 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896527
- Sponsor's protocol ID
- DCE806201
- Other IDs
- 2022-502249-90-00, J5B-MC-FHAG
- Acronym
- Illuminate
- Status last verified
- Mar 2025
- First submitted
- 31 May 2023
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05896527
- Acronym / sponsor ID
- Illuminate / DCE806201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo tablets orally twice daily (BID) for 12 weeks. |
| DC-806 200 mg BID | Experimental | Drug: DC-806Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks. |
| DC-806 400 mg BID | Experimental | Drug: DC-806Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks. |
| DC-806 600 mg QD | Experimental | Drug: DC-806Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks. |
| DC-806 800 mg BID | Experimental | Drug: DC-806Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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 (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-806DC-806 was supplied as tablets to be administered orally. | Drug | DC-806 200 mg BID, DC-806 400 mg BID, DC-806 600 mg QD, DC-806 800 mg BID |
| PlaceboMatching placebo was supplied as tablets to be administered orally. | Other | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
56 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DC-806 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 56 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Canada, Germany, Poland, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.