Hidradenitis Suppurativa (HS)Phase 1NCT07828860
Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa
A Phase 1 study testing Soquelitinib in people with Hidradenitis Suppurativa (HS), run by Corvus Pharmaceuticals, Inc. at 11 sites in United States.
Trial summary
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Soquelitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Sep 2026to Dec 2027
- Phase
- Phase 1
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 the time of signing the informed consent form (ICF)
- A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.
- A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits.
- Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.
- HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline (Day 1) visits.
- History of inadequate response, intolerance, or contraindication to a course of systemic antibiotics for treatment of HS or exhibited recurrence after discontinuation of antibiotics through study participant interview and/or review of medical history.
- Willing and able to undergo the required skin biopsies.
Who cannot join
- Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study intervention on HS.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions.
- Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline (Day 1).
- 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 study; 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 (eg, 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
Clinical Site 3
Boston, Massachusetts, 02215
- Recruiting
Clinical Site 1
Bowling Green, Kentucky, 42104
- Recruiting
Clinical Site 6
Camp Hill, Pennsylvania, 17011
- Recruiting
Clinical Site 11
Fargo, North Dakota, 58103
- Recruiting
Clinical Site 10
Mayfield Heights, Ohio, 44124
- Recruiting
Clinical Site 7
Nashville, Tennessee, 37211
- Recruiting
Clinical Site 5
New York, New York, 10023
- Recruiting
Clinical Site 2
Owensboro, Kentucky, 42303
- Recruiting
Clinical Site 8
Philadelphia, Pennsylvania, 19103
- Recruiting
Clinical Site 4
The Bronx, New York, 10455
- Not yet recruiting
Clinical Site 9
West Lafayette, Indiana, 47906
About this study
Official title: A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
Read the detailed description
A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults with Moderate-to-Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Soquelitinib
- Medical subject headings
- Hidradenitis Suppurativa
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
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Other | Participants receive open-label single arm of active tablets orally twice daily for 84 days. Receives: Drug: Soquelitinib |
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 ECGs
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs
Measured: up to 30 days after last intervention administration
Secondary outcomes (6)
1) percentage of participants achieving HiSCR50 2) percentage of participants achieving HiSCR75 3) percentage of participants achieving HiSCR90
HiSCR is a validated clinical endpoint used to assess the inflammatory signs and symptoms of HS. HiSCR evaluation is based in count of active HS lesions including abscesses, inflammatory nodules and draining tunnels (fistulas). The sum of abscesses and inflammatory nodules constitutes the total AN count.
Measured: Week 12
Efficacy as measured by Hidradenitis Suppurativa Severity Score System (IHS4)
IHS4 captures the inflammatory burden of draining tunnels, inflammatory nodules and abscesses. Different weights are assigned to each lesion type: inflammatory nodules (1 point), abscesses (2 points), and draining tunnels (4 points). The number of each lesion type is multiplied by its respective weight, and the three obtained values are then summed to obtain the total IHS4 score.
Measured: Week 12
Efficacy as measured by change and percentage change in lesion count
Lesion count includes abscess count, inflammatory nodule count, abscess and inflammatory nodule [AN] count, draining tunnel count
Measured: Week 12
1) at least 30% reduction and at least 1-pt reduction and 2) at least 3-pt reduction from Baseline in the weekly average of daily HS-Skin Pain NRS
The Skin Pain-NRS is used to assess participants self-reported severity of worst skin pain each day. The NRS is an 11-point scale (0 to 10), with 0 indicating "no pain" and 10 indicating the "worst pain imaginable" in a 24-hour recall period.
Measured: Week 12
Evaluate change from baseline in Hidradenitis Suupurativa Quality of Life (HiSQoL) Score
HiSQoL is 17-item questionnaire to assess HS-specific health-related quality of life which has a recall period of 7 days. The HiSQoL includes 3 subscales: symptom status, psychosocial impact, and impact on physical activities. Individual item scores are summed and a total score ranging from 0 to 68 is calculated, where the higher the score the more impact HS has on quality of life.
Measured: Week 12
Evaluate change from baseline in Dermatology Life Quality Index (DLQI)
DLQI is a 10-item, validated, quality of life questionnaire. Participants assess their quality of life across 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Response options with corresponding scores are "not at all" (0), "a lot" (1), and "very much" (3), and "not relevant" or unanswered responses scored as 0. Participants with higher total scores indicate greater impairment of quality of life. A 4-point change from Baseline is considered the minimal clinically important difference threshold
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start17 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isin Sinem Bagci, MD, Study director, Corvus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828860
- Sponsor's protocol ID
- CPI-818-010
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No