Plaque PsoriasisPhase 1NCT06808815
A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque Psoriasis
A Phase 1 study testing DC-806 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to learn more about the safety and side effects of DC-806 when given by mouth to healthy participants and participants with Chronic Plaque Psoriasis. The study will have three parts. Each participant will enroll in only one part. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2021to 23 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects (Parts 1 and 2)
- Men and women participants must be between 18-55 years inclusive, at the time of informed consent.
- Female participants must either be of non-childbearing potential or if of childbearing potential, must not be pregnant, breast feeding or lactating and use a highly effective birth control method during treatment and for 90 days following last administered dose. In addition, male partners of female subjects of childbearing potential must use highly effective contraception for 90 days following the last administered dose
- Male participants who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after their last dose of IMP.
- Participants must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP.
- Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
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- Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator or designee.
- Participants with Psoriasis (Part 3)
- Men and women Participants must be between 18-65 years inclusive, at the time of informed consent.
- Participants must have a documented diagnosis of plaque psoriasis for ≥ 6 months prior to screening.
- Physicians Global Assessment (PGA) of 2/3 i.e. mild or moderate plaque psoriasis at baseline.
- Body Surface Area (BSA) ≥3% at baseline.
- A minimum of 2 psoriatic lesions of at least 2 cm x 2 cm at baseline, with at least 1 plaque in a site suitable for biopsy.
- Female participants must either be of non-childbearing potential or if of childbearing potential, must not be pregnant, breast feeding or lactating and use a highly effective birth control method during treatment and for 90 days following last administered dose. In addition, male partners of female subjects of childbearing potential must use highly effective contraception for 90 days following the last administered dose.
- Male participants who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after their last dose of IMP.
- Participants must have a body mass index (BMI) ≥ 18 and ≤ 36 kg/m2.
Who cannot join
- Healthy Subjects (Parts 1 and 2)
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator or designee.
- After 10 minutes supine rest at the time of screening or prior to dosing on Day 1, any vital signs values outside the following ranges:
- Systolic blood pressure <90 or >150 mmHg, or
- Diastolic blood pressure <50 or >95 mmHg, or
- Pulse <40 or >90 bpm
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- Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (>450 ms for males; >470 ms for females using the mean of triplicate ECG's) and cardiac arrhythmias, as judged by the Investigator or designee.
- Clinically significant abnormalities in renal function:
- eGFR <60 mL/min
- Clinically significant abnormalities in liver function:
- Bilirubin >1.5 x ULN
- Aminotransferases >1.5 x ULN
- ALP >1.5 x ULN
- History of latent TB, active tuberculosis, or a positive QuantiFERON® TB Gold result at screening. Patients with an indeterminate QuantiFERON® TB Gold result at screening will be allowed one retest; if not negative on retesting, the subject will be excluded.
- Females who are pregnant, breast feeding or plan to be pregnant during the study period or 90 days after.
- Female subjects with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at screening or within 24 h prior to the first administration of IMP.
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- Part 2 Only: Presence of active suicidal ideation or positive suicide behaviour using the "Baseline/Screening" version of the Columbia Suicide Severity Rating Scale (C-SSRS) and with either of the following criteria:
- History of a suicide attempt within the 5 years prior to the Screening Visit. Subjects with a history of a suicide attempt more than 5 years ago should be evaluated by a mental healthcare professional (eg, locally licensed psychiatrist, psychologist, or master's level therapist) before enrolling into the study.
- Suicidal ideation in the past month prior to 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.
- Participants with Psoriasis (Part 3)
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition other than psoriasis that could interfere with the patient's safety during the clinical study or expose the patient to undue risk as judged by the Investigator or designee.
- A diagnosis of non-plaque psoriasis.
- Plaque psoriasis restricted to the scalp, palms, soles and face.
- Pustular, erythrodermic, inverse, and guttate psoriasis
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a subject requires current systemic (oral, SC, or IV) (including corticosteroids, immunosuppressants, biologics) immunosuppressant medical treatment
- Treatment with biologics within 5 half-lives (if known) or 6 months prior to dosing on Day 1, whichever is longer
- Has received any systemic immunosuppressants (e.g. Methotrexate, cyclosporine, hydroxyurea, and tacrolimus) or anakinra within 4 weeks of the first administration of study medication.
- Has received phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, psoralens, sulfasalazine, hydroxyurea, apremilast, or fumaric acid derivatives) within 4 weeks of the first administration of study medication
- Has used topical medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, picrolimus, and tacrolimus) within 2 weeks of the first administration of study medication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Medicines Evaluation Unit (MEU) Ltd.
Manchester, M23 9QZ
About this study
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Ascending Doses of S011806 in Healthy Participants and Multiple Doses of S011806 in Patients With Chronic Plaque Psoriasis
The main purpose of this study is to learn more about the safety and side effects of DC-806 when given by mouth to healthy participants and participants with Chronic Plaque Psoriasis. The study will have three parts. Each participant will enroll in only one part. For each participant, Part 1 will last up to 14 weeks, Part 2 will last up to 12 weeks, Part 3 will last up to 11 weeks including screening and follow-up.
- 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
Also called S011806, LY4100504
administered orally.
PlaceboOther
administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: DC-806 | Experimental | Single ascending dose of DC-806 administered orally. Receives: Drug: DC-806 |
| Part 1: Placebo | Placebo comparator | Placebo administered orally. Receives: Other: Placebo |
| Part 2: DC-806 | Experimental | Multiple ascending doses of DC-806 administered orally. Receives: Drug: DC-806 |
| Part 2: Placebo | Placebo comparator | Placebo administered orally Receives: Other: Placebo |
| Part 3:DC-806 | Experimental | DC-806 administered orally Receives: Drug: DC-806 |
| Part 3: Placebo | Placebo comparator | Placebo administered orally Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
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.
Measured: Baseline Up To 7 Weeks
Part 2: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
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.
Measured: Baseline Up To 7 Weeks
Part 3: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
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.
Measured: Baseline Up To 11 Weeks
Secondary outcomes (10)
Part 1, Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of DC-806.
PK: Cmax of DC-806.
Measured: Pre-dose up-to 48 hours post-dose
Part 1, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806.
PK: AUC of DC-806.
Measured: Pre-dose up-to 48 hours post-dose
Part 1, PK: Time to reach maximum observed (Tmax) of DC-806
PK: Tmax of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 1, PK: First-order elimination half-life (T1/2) of DC-806
PK: Half-life (T1/2) DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 2, PK: Maximum Observed Concentration (Cmax) of DC-806
PK: Cmax of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 2, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806
PK: AUC of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 2, PK: Time to reach maximum observed (Tmax) of DC-806
PK: Tmax of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 2, PK: First-order elimination half-life (T1/2) of DC-806
PK: Half-life (T1/2) DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 3, PK: Maximum Observed Concentration (Cmax) of DC-806
PK: Cmax of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Part 3, PK: Ctrough of DC-806
pre-dose of DC-806
Measured: Pre-dose up-to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start22 Sep 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 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 W 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
- NCT06808815
- Sponsor's protocol ID
- DCE806101
- Other IDs
- 2021-002888-21, J5B-MC-FHAB, 297326, 18850
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Ascending Doses of S011806 in Healthy Participants and Multiple Doses of S011806 in Patients With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06808815
- Acronym / sponsor ID
- DCE806101
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to learn more about the safety and side effects of DC-806 when given by mouth to healthy participants and participants with Chronic Plaque Psoriasis. The study will have three parts. Each participant will enroll in only one part. For each participant, Part 1 will last up to 14 weeks, Part 2 will last up to 12 weeks, Part 3 will last up to 11 weeks including screening and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: DC-806 | Experimental | Drug: DC-806Single ascending dose of DC-806 administered orally. |
| Part 1: Placebo | Placebo comparator | Other: PlaceboPlacebo administered orally. |
| Part 2: DC-806 | Experimental | Drug: DC-806Multiple ascending doses of DC-806 administered orally. |
| Part 2: Placebo | Placebo comparator | Other: PlaceboPlacebo administered orally |
| Part 3:DC-806 | Experimental | Drug: DC-806DC-806 administered orally |
| Part 3: Placebo | Placebo comparator | Other: PlaceboPlacebo administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy Subjects (Parts 1 and 2)
- Men and women participants must be between 18-55 years inclusive, at the time of informed consent.
- Female participants must either be of non-childbearing potential or if of childbearing potential, must not be pregnant, breast feeding or lactating and use a highly effective birth control method during treatment and for 90 days following last administered dose. In addition, male partners of female subjects of childbearing potential must use highly effective contraception for 90 days following the last administered dose
- Male participants who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after their last dose of IMP.
- Participants must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP.
Key exclusion criteria (31 listed)
- Healthy Subjects (Parts 1 and 2)
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator or designee.
- After 10 minutes supine rest at the time of screening or prior to dosing on Day 1, any vital signs values outside the following ranges:
- Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (>450 ms for males; >470 ms for females using the mean of triplicate ECG's) and cardiac arrhythmias, as judged by the Investigator or designee.
- Clinically significant abnormalities in renal function:
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-806Also: S011806, LY4100504administered orally. | Drug | Part 1: DC-806, Part 2: DC-806, Part 3:DC-806 |
| Placeboadministered orally. | Other | Part 1: Placebo, Part 2: Placebo, Part 3: Placebo |
Primary outcome
Part 1: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Time frame: Baseline Up To 7 Weeks
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.
Part 2: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Time frame: Baseline Up To 7 Weeks
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.
Part 3: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.
Time frame: Baseline Up To 11 Weeks
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.
10 secondary outcomes
Part 1, Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of DC-806.
Time frame: Pre-dose up-to 48 hours post-dose
Part 1, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806.
Time frame: Pre-dose up-to 48 hours post-dose
Part 1, PK: Time to reach maximum observed (Tmax) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 1, PK: First-order elimination half-life (T1/2) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 2, PK: Maximum Observed Concentration (Cmax) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 2, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 2, PK: Time to reach maximum observed (Tmax) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 2, PK: First-order elimination half-life (T1/2) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 3, PK: Maximum Observed Concentration (Cmax) of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Part 3, PK: Ctrough of DC-806
Time frame: Pre-dose up-to 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- 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 W Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC-806 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United Kingdom.
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 16 inclusion and 31 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug. (time frame: Baseline Up To 7 Weeks). The study lists 3 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 5 Feb 2025.