Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis suppurativa, Hidradenitis, Skin diseases, Sweat gland diseases, Skin and connective tissue diseases
Brief summary
This Phase 2 study will test whether the investigational medicine, SPY072, improves hidradenitis suppurativa (HS) in adults with moderate to severe disease receiving advanced standard of care treatment. About 150 participants will be assigned by chance to receive either SPY072 or placebo for 16 weeks. Participants will be followed after the treatment period to evaluate safety and how long treatment effects may last.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study of SPY072 in adults 18 to 75 years of age with moderate to severe HS who are receiving advanced standard of care treatment. After a screening period, approximately 150 eligible participants will be randomized to SPY072 or matching placebo through Week 16. After completion of treatment, participants will then enter a follow-up period.
Interventions
DRUGSPY072
Solution for SC injection
DRUGPlacebo
Matching placebo for SC injection
DRUGbimekizumab
Advanced standard of care
Sponsors
Spyre Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two parallel treatment arms; SPY072 or matching placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening. * Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day 1. * Total abscess and/or inflammatory nodule count of at least 5 at screening and Day 1. * Documented inadequate response, intolerance, or contraindication to at least 1 systemic therapy for hidradenitis suppurativa.
Exclusion criteria
* More than 20 draining tunnels at screening or Day 1. * Hidradenitis suppurativa lesion expected to require incision and drainage within 4 weeks before Day 1, or major hidradenitis suppurativa surgery within 12 weeks before Day 1. * Another inflammatory or skin condition that could interfere with assessment of hidradenitis suppurativa.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | Week 16 | HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | Week 16 | HiSCR50 is defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count. |
| Treatment-emergent Adverse Events (TEAEs) | Up to 52 weeks | Incidence, severity and causal relationship of TEAEs |
Countries
United States
Contacts
CONTACTSKYLIGHT Trial Center
STUDY_DIRECTORJoshua Friedman, MD, PhD
Spyre Therapeutics, Inc.
Outcome results
None listed