Hidradenitis Suppurativa (HS)
Conditions
Brief summary
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
Detailed description
A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults with Moderate-to-Severe Hidradenitis Suppurativa
Interventions
DRUGSoquelitinib
Tablets
Sponsors
Corvus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. Key
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events, changes in laboratory values, vital signs, and ECGs | up to 30 days after last intervention administration | Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1) percentage of participants achieving HiSCR50 2) percentage of participants achieving HiSCR75 3) percentage of participants achieving HiSCR90 | Week 12 | 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. |
| Efficacy as measured by Hidradenitis Suppurativa Severity Score System (IHS4) | Week 12 | 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. |
| Efficacy as measured by change and percentage change in lesion count | Week 12 | Lesion count includes abscess count, inflammatory nodule count, abscess and inflammatory nodule \[AN\] count, draining tunnel count |
| 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 | Week 12 | 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. |
| Evaluate change from baseline in Hidradenitis Suupurativa Quality of Life (HiSQoL) Score | Week 12 | 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. |
| Evaluate change from baseline in Dermatology Life Quality Index (DLQI) | Week 12 | 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 |
Countries
United States
Contacts
CONTACTCorvus Trials Inquiry
STUDY_DIRECTORIsin Sinem Bagci, MD
Corvus Pharmaceuticals, Inc.
Outcome results
None listed