This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
149
Solution in autoinjector for subcutaneous (SC) injection
Solution in autoinjector for SC injection
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
The percentage of participants with ≥50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.
Time frame: Week 16
Percentage of Participants Achieving HiSCR75 at Week 16
The percentage of participants with ≥75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75) will be reported.
Time frame: Week 16
Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.
Time frame: Week 16
Percentage of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.
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Cahaba Dermatology & Skin Health Center ( Site 0012)
Birmingham, Alabama, United States
Medical Dermatology Specialists ( Site 0027)
Phoenix, Arizona, United States
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)
Rogers, Arkansas, United States
Northridge Clinical Trials ( Site 0004)
Northridge, California, United States
Integrative Skin Science and Research ( Site 0015)
Sacramento, California, United States
Olympian Clinical Research ( Site 0010)
Tampa, Florida, United States
Skin Care Physicians of Georgia ( Site 0033)
Macon, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center ( Site 0044)
Boston, Massachusetts, United States
Revival Research Institute, LLC ( Site 0005)
Troy, Michigan, United States
...and 58 more locations
Time frame: Up to ~130 weeks
Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.
Time frame: Up to ~116 weeks