A Phase 1 interventional study of Soquelitinib in Hidradenitis Suppurativa (HS), sponsored by Corvus Pharmaceuticals, Inc.. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Corvus Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults with Moderate-to-Severe Hidradenitis Suppurativa
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 25 is below the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Corvus Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive open-label single arm of active tablets orally twice daily for 84 days.
Drug: Soquelitinib
Tablets
Also known as: CPI-818
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
Time frame: up to 30 days after last intervention administration
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Soquelitinib
Corvus Pharmaceuticals, Inc.