Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Sponsors
ACELYRIN, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject (male and female) must be = 18 and = 75 years - Diagnosis of HS for = 1 year - HS lesions present in = 2 distinct anatomic areas, one of Hurley Stage II or Hurley Stage III - A total AN count of = 3 at screening - Subject must have had an inadequate response to oral antibiotics (defined as = 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS - Subject must agree to use daily (throughout the duration of the study) one of the following over-the-counter topical antiseptics on their body areas affected with HS suppurativa lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or diluted bleach in bathwater. - Subject must be willing to complete a daily skin pain diary 7 consecutive days prior to Day 1 - No known history of active tuberculosis - Subject has a negative tuberculosis test at screening - Male and Female participants of childbearing potential must use effective methods of contraception For a complete overview of the inclusion criteria refer to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 162 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: - Draining fistula count of > 20 at screening or Day 1 prior to enrollment/randomization - Outpatient surgery = 8 weeks prior or inpatient surgery = 12 weeks prior to enrollment/randomization - Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments - History of major autoimmune, chronic inflammatory, or connective tissue disease (eg, rheumatoid arthritis, psoriasis, psoriatic arthritis, axial spondyloarthritis, system lupus erythematosus, IBD) other than HS - Chronic pain not associated with HS (eg, fibromyalgia). - Uncontrolled, clinically significant system disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), renal disease, liver disease or hypertension - History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease - Malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma - The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. Subjects must have been on a stable dose within the 3 months prior to the first dose of study intervention - History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the Investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion - Any active infection for which oral anti-infectives (antibiotics, antivirals, antifungals) were used = 14 days prior to first dose of study intervention (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS) - A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) = 30 days prior to first dose of study intervention - Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject - Candida infection requiring systemic treatment = 3 months prior to first dose of study intervention - Tuberculosis or fungal infection seen on available chest x-ray taken = 3 months of screening or at screening - Known history of human immunodeficiency virus (HIV) - Previous exposure to izokibep or any other IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab) - Prior exposure to biologics that had a potential or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri ®], rituximab [Rituxan®], or efalizumab [Raptiva®]) - Exposure to TNF-a inhibitors, IL-1, IL-12, IL-23, or IL-12/23 receptor inhibitors within 5 half-lives prior to first dose of study intervention - Exposure to the following = 12 weeks prior to first dose of study intervention • Other experimental or commercially available biologic or biosimilar therapies (within 12 weeks or 5 half-lives, whichever is longer) • IV gamma-globulin or Prosorba column therapy • Exposure to the following = 4 weeks prior to first dose of study intervention • JAK inhibit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A - To explore the efficacy of izokibep as measured by HiSCR at Week 16 Part B - To demonstrate that one or both treatment regimens of izokibep is efficacious compared to placebo, as measured by HiSCR at Week 16;Secondary Objective: Part A - To explore the safety and tolerability - To explore the immunogenicity of izokibep as measured by the presence of ADAs Part B -To demonstrate that one or both regimens of izokibep is efficacious, as measured by: • Percentage of subjects achieving at least 30% reduction from baseline in NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS =3 • Percentage of subjects that experience = 1 disease flare after 16 weeks of treatment • Percentage of subjects with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16. - To assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of interest, SAEs, and clinically significant laboratory values and vital signs - To assess the immunogenicity of izokibep as measured by the presence of ADAs;Primary end point(s): Part A HiSCR = hidradenitis suppurativa clinical response at week 16 Part b HiSCR at week 16;Timepoint(s) of evaluation of this end point: Part A HiSCR - at Week 16 Part B HiSCR - at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A - TEAEs and SAEs - Laboratory values and vital signs at collected timepoints - ADAs (= anti-drug antibodies) Part B - NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16 - HS flares through Week 16 - AN count of 0, 1, or 2 at Week 16 - TEAEs, events of interest, and SAEs - Laboratory values and vital signs at collected timepoints -ADAs;Timepoint(s) of evaluation of this end point: Part A and Part B - TEAEs and SAEs events of interest - Laboratory values and vital signs at collected timepoints - ADAs (= anti-drug antibodies) From start of treatment to end of study. - NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16 - HS flares through Week 16 - AN count of 0, 1, or 2 at Week 16 | — |
Countries
Canada, Germany, Hungary, Poland, Spain, United States
Contacts
Public ContactClinical Trial Information Desk
ACELYRIN, Inc.
Outcome results
None listed