Hidradenitis Suppurativa
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGTulisokibart
Solution in autoinjector for subcutaneous (SC) injection
DRUGPlacebo
Solution in autoinjector for SC injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening * Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III * Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS * Has ≤20 draining tunnel count at Screening and Randomization
Exclusion criteria
* Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS * Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy * Has a transplanted organ and requires continued systemic immunosuppression * Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years * Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments * Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Has any active infection * Has active tuberculosis * Has had major surgery within the past 3 months or has a major surgery planned during the study * Has a history of clinically significant drug or alcohol abuse within the past 6 months * Has prior exposure to tulisokibart * Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving HiSCR75 at Week 16 | 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. |
| Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | 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. |
| Percentage of Participants Who Experience One or More Adverse Events (AEs) | Up to ~130 weeks | 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. |
| Percentage of Participants Who Discontinue Study Intervention Due to an AE | Up to ~116 weeks | 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. |
Countries
Argentina, Australia, Canada, Chile, China, Colombia, France, Germany, Italy, Japan, Netherlands, Singapore, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed