Hidradenitis Suppurativa study: SPY072 vs Bimekizumab
Official title A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
ClinicalTrials.gov ID: NCT07766005
What this study is testing
What is SPY072?
SPY072 is an investigational once‑daily subcutaneous injection being studied as a potential treatment for hidradenitis suppurativa.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if SPY072 can improve HS symptoms in adults who are already receiving advanced standard care. It will also look at safety and how long any benefits last.
- Who it's for
- Adults with moderate to severe hidradenitis suppurativa who are receiving advanced standard of care treatment.
- What's involved
- Participants will be randomly given either SPY072 or a placebo for 16 weeks. They will have regular visits and tests to monitor their condition and any side effects. After the 16‑week period, they will be followed up to check safety and lasting effects.
- Time commitment
- The study lasts 16 weeks of treatment, with additional follow‑up visits after that period to monitor safety and outcomes.
- Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Another inflammatory or skin condition that could interfere with assessment of hidradenitis suppurativa.
The study team makes the final eligibility decision.
Where it is enrolling
- Indianapolis, Indiana, United States
- Bowling Green, Kentucky, United States
- Owensboro, Kentucky, United States
- New York, New York, United States
- The Bronx, New York, United States
- Nashville, Tennessee, United States
- Tyler, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Indianapolis, Indiana, United States; Bowling Green, Kentucky, United States; Owensboro, Kentucky, United States; New York, New York, United States; The Bronx, New York, United States; Nashville, Tennessee, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.