Atopic DermatitisPhase 1NCT06345404
Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD
A Phase 1 study testing Soquelitinib in people with Atopic Dermatitis, run by Corvus Pharmaceuticals, Inc. at 16 sites in United States.
Trial summary
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Soquelitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 16 sitesUnited States
- Study dates
- 16 Apr 2024to 24 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female, ≥18 years of age at Screening.
- Atopic dermatitis, according to Hanifin and Rajka criteria and confirmed by a dermatologist.
- Moderate to severe disease defined by EASI ≥16; body surface area ≥10; and vIGA ≥3.
- Documented history of inadequate response or intolerance to one or more topical therapies (including but not limited to corticosteroids, immune modulators, PDE-4 inhibitors) and/or systemic therapies (including but not limited to, dupilumab, cyclosporine, mycophenolate, azathioprine, oral corticosteroids or a JAK inhibitor, e.g., tofacitinib, baricitinib, and ruxolitinib).
- A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after last dose of study treatment
Who cannot join
- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or would interfere with the appropriate assessment of AD lesions.
- Administration of oral prednisone or its equivalent within 2 weeks of starting the trial or receiving corticosteroids parenterally within 4 weeks of Screening.
- Administration of oral or injectable immunosuppressive medications such as methotrexate, mycophenolate, azathioprine, cyclosporine, dupixent, a janus kinase inhibitor or tacrolimus (except that topical is allowed) within 4 weeks of Screening.
- Active use of phototherapy, attending a tanning booth, or extended sun exposure which could affect judging disease activity.
- Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 120 days after the last dose of study intervention.
Show all 17Show fewer
- Male participant who is considering fathering a child or donating sperm during the study or for approximately 120 days after the last dose of study intervention.
- History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal function, or abnormal liver function), planned surgical procedures, or any other reason which in the opinion of the investigator or Sponsor would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study intervention, or would put the participant at risk by participating in the protocol; or permanently wheelchair-bound or bedridden or very poor functional status which prevents the ability to perform self-care.
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (e.g., unstable angina, unstable arterial hypertension, moderate to severe heart failure [New York Heart Association Class III/IV]), respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.
- Participants with renal function which is moderately or severely impaired, defined as an estimated glomerular filtration rate (eGFR) ≤59 ml/minute.
- Participants with abnormal liver function as recognized by the FDA and as defined by the Child-Pugh criteria. Specifically, participants must show no signs of encephalopathy, have no ascites, have a serum bilirubin ≤2.0 mg/dL, have a serum albumin ≥3.5 g/dL, and have a prothrombin time prolonged by no more than 4 seconds.
- Any of the following laboratory values would preclude participation in this trial:
- Hematocrit <30%
- Neutrophil count <2000/μl
- Liver enzymes ≥2 × upper limit of normal (ULN)
- Platelet count <100,000/μl
- Participants who cannot ingest medications orally or who have malabsorption.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Clinical Site 5
Birmingham, Alabama, 35244
Clinical Site 11
Brooklyn, New York, 11203
Clinical Site 1
Camp Hill, Pennsylvania, 17011
Clinical Site 10
Castle Rock, Colorado, 80109
Clinical Site 2
Fremont, California, 94538
Clinical Site 4
Frisco, Texas, 75034
Clinical Site 15
Mayfield Heights, Ohio, 44124
Clinical Site 16
New York, New York, 10023
Clinical Site 12
New York, New York, 10075
Clinical Site 3
North Little Rock, Arkansas, 72117
Clinical Site 7
Palo Alto, California, 94063
Clinical Site 8
Philadelphia, Pennsylvania, 19103
Clinical Site 13
Pomona, California, 91767
Clinical Site 14
San Antonio, Texas, 78213
Clinical Site 6
Tampa, Florida, 33615
Clinical Site 9
Tucson, Arizona, 85704
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD
Read the detailed description
A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants with Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- Soquelitinib, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoquelitinibDrug
Also called CPI-818
Tablets
PlaceboDrug
Soquelitinib matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Soquelitinib Dose Escalation and Dose Expansion | Experimental | In Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days.
In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days Receives: Drug: Soquelitinib |
| Placebo | Placebo comparator | Participants in the Dose Escalation part of the study will receive placebo tablets orally once daily or twice daily for 28 days.
Participants in the Dose Expansion part of the study will receive placebo tablets orally once daily or twice daily for 56 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
Measured: Up to 30 days after last intervention administration
Secondary outcomes (2)
To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Measured: Up to 90 days after last intervention administration
To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1
The vIGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
Measured: Up to 90 days after last intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start16 Apr 2024
- Primary completion28 Jan 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Sequential
- Model description
- Sequential Dose Escalation and Dose Expansion
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suresh Mahabhashyam, MD, Study director, Corvus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345404
- Sponsor's protocol ID
- CPI-818-003
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06345404
- Acronym / sponsor ID
- CPI-818-003
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 3 Apr 2024 (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.
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD
Detailed description
A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants with Moderate to Severe Atopic Dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Dose Escalation and Dose Expansion
| Arm | Type | Receives |
|---|---|---|
| Soquelitinib Dose Escalation and Dose Expansion | Experimental | Drug: SoquelitinibIn Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days. In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in the Dose Escalation part of the study will receive placebo tablets orally once daily or twice daily for 28 days. Participants in the Dose Expansion part of the study will receive placebo tablets orally once daily or twice daily for 56 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult male or female, ≥18 years of age at Screening.
- Atopic dermatitis, according to Hanifin and Rajka criteria and confirmed by a dermatologist.
- Moderate to severe disease defined by EASI ≥16; body surface area ≥10; and vIGA ≥3.
- Documented history of inadequate response or intolerance to one or more topical therapies (including but not limited to corticosteroids, immune modulators, PDE-4 inhibitors) and/or systemic therapies (including but not limited to, dupilumab, cyclosporine, mycophenolate, azathioprine, oral corticosteroids or a JAK inhibitor, e.g., tofacitinib, baricitinib, and ruxolitinib).
- A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
Key exclusion criteria (17 listed)
- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or would interfere with the appropriate assessment of AD lesions.
- Administration of oral prednisone or its equivalent within 2 weeks of starting the trial or receiving corticosteroids parenterally within 4 weeks of Screening.
- Administration of oral or injectable immunosuppressive medications such as methotrexate, mycophenolate, azathioprine, cyclosporine, dupixent, a janus kinase inhibitor or tacrolimus (except that topical is allowed) within 4 weeks of Screening.
- Active use of phototherapy, attending a tanning booth, or extended sun exposure which could affect judging disease activity.
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 |
|---|---|---|
| SoquelitinibAlso: CPI-818Tablets | Drug | Soquelitinib Dose Escalation and Dose Expansion |
| PlaceboSoquelitinib matching placebo tablets | Drug | Placebo |
Primary outcome
Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms
Time frame: Up to 30 days after last intervention administration
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
2 secondary outcomes
To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)
Time frame: Up to 90 days after last intervention administration
To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1
Time frame: Up to 90 days after last intervention administration
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 12 Mar 2026.
- 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.
Suresh Mahabhashyam, MD study director
Corvus Pharmaceuticals, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Soquelitinib in people with Atopic Dermatitis, run by Corvus Pharmaceuticals, Inc. at 16 sites in United States.
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 17 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms (time frame: Up to 30 days after last intervention administration). 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 12 Mar 2026.