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A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)

ConditionHidradenitis Suppurativa (HS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSpyre Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPY072

    Drug

    Solution for SC injection

  • Placebo

    Drug

    Matching placebo for SC injection

  • bimekizumab

    Drug

    Advanced standard of care

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: SPY072 + bimekizumabExperimental treatment 2 interventions
Group B: Placebo + bimekizumabPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

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

Time frame
Week 16

Secondary outcomes

1

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

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.

Time frame
Week 16
2

Treatment-emergent Adverse Events (TEAEs)

Incidence, severity and causal relationship of TEAEs

Time frame
Up to 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spyre Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: