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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Tablets
Clinical Site 9
West Lafayette, Indiana, United States
NOT_YET_RECRUITINGClinical Site 1
Bowling Green, Kentucky, United States
RECRUITINGIncidence 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.
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Clinical Site 2
Owensboro, Kentucky, United States
RECRUITINGClinical Site 3
Boston, Massachusetts, United States
NOT_YET_RECRUITINGClinical Site 5
New York, New York, United States
RECRUITINGClinical Site 4
The Bronx, New York, United States
RECRUITINGClinical Site 11
Fargo, North Dakota, United States
NOT_YET_RECRUITINGClinical Site 10
Mayfield Heights, Ohio, United States
RECRUITINGClinical Site 6
Camp Hill, Pennsylvania, United States
NOT_YET_RECRUITINGClinical Site 8
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITING...and 1 more locations
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