Hidradenitis Suppurativa (HS)Phase 2NCT07766005
A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
A Phase 2 study testing SPY072 and bimekizumab in people with Hidradenitis Suppurativa (HS), run by Spyre Therapeutics, Inc. at 34 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- SPY072 and bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Sep 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
34 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 2 countries
United States26 sites, 26 recruiting
- Not yet recruiting
Site 115
Atlanta, Georgia, 30329
SKYLIGHT Trial Center
- Not yet recruiting
Site 108
Baton Rouge, Louisiana, 70809
SKYLIGHT Trial Center
- Not yet recruiting
Site 117
Birmingham, Alabama, 35244
SKYLIGHT Trial Center
- Not yet recruiting
Site 103
Boston, Massachusetts, 02115
SKYLIGHT Trial Center
- Not yet recruiting
Site 112
Boston, Massachusetts, 02115
SKYLIGHT Trial Center
- Recruiting
Site 100
Bowling Green, Kentucky, 42104
SKYLIGHT Trial Center
- Not yet recruiting
Site 113
Coral Gables, Florida, 33134
SKYLIGHT Trial Center
- Not yet recruiting
Site 127
Detroit, Michigan, 48202
SKYLIGHT Trial Center
- Not yet recruiting
Site 124
Durham, North Carolina, 27710
SKYLIGHT Trial Center
- Recruiting
Site 101
Indianapolis, Indiana, 46250
SKYLIGHT Trial Center
- Not yet recruiting
Site 111
Irvine, California, 92614
SKYLIGHT Trial Center
- Not yet recruiting
Site 120
Las Vegas, Nevada, 89119
SKYLIGHT Trial Center
- Not yet recruiting
Site 126
Las Vegas, Nevada, 89145
SKYLIGHT Trial Center
- Not yet recruiting
Site 106
Mill Creek, Washington, 98012
SKYLIGHT Trial Center
- Not yet recruiting
Site 109
Mt. Pleasant, South Carolina, 29464
SKYLIGHT Trial Center
- Not yet recruiting
Site 123
Murray, Utah, 84107
SKYLIGHT Trial Center
- Recruiting
Site 125
Nashville, Tennessee, 37211
SKYLIGHT Trial Center
- Recruiting
Site 102
New York, New York, 10023
SKYLIGHT Trial Center
- Not yet recruiting
Site 122
Oklahoma City, Oklahoma, 73118
SKYLIGHT Trial Center
- Recruiting
Site 116
Owensboro, Kentucky, 42303
SKYLIGHT Trial Center
- Not yet recruiting
Site 114
Prosper, Texas, 75078
SKYLIGHT Trial Center
- Not yet recruiting
Site 119
Rogers, Arkansas, 72758
SKYLIGHT Trial Center
- Not yet recruiting
Site 118
Smyrna, Tennessee, 37617
SKYLIGHT Trial Center
- Recruiting
Site 104
The Bronx, New York, 10455
SKYLIGHT Trial Center
- Recruiting
Site 107
Tyler, Texas, 75703
SKYLIGHT Trial Center
- Not yet recruiting
Site 121
Tyler, Texas, 75703
SKYLIGHT Trial Center
Canada8 sites, 8 recruiting
- Not yet recruiting
Site 160
Barrie, Ontario, L4M 7G1
SKYLIGHT Trial Center
- Not yet recruiting
Site 163
Edmonton, Alberta, T6G 1C3
SKYLIGHT Trial Center
- Not yet recruiting
Site 167
Markham, Ontario, L3P 1X2
SKYLIGHT Trial Center
- Not yet recruiting
Site 166
Québec, Quebec, G1M 2S8
SKYLIGHT Trial Center
- Not yet recruiting
Site 162
Richmond Hill, Ontario, L4B 1A5
SKYLIGHT Trial Center
- Not yet recruiting
Site 161
Saskatoon, Saskatchewan, S7T 0G3
SKYLIGHT Trial Center
- Not yet recruiting
Site 165
Surrey, British Columbia, V3V 0C6
SKYLIGHT Trial Center
- Not yet recruiting
Site 164
Winnipeg, Manitoba, R3M 3Z4
SKYLIGHT Trial Center
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Assess the Efficacy and Safety of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa Receiving Standard of Care Treatment
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- SPY072, Placebo, bimekizumab
- Keywords
- Hidradenitis suppurativa, Hidradenitis, Skin diseases, Sweat gland diseases, Skin and connective tissue diseases
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis, Skin Diseases, Sweat Gland Diseases, Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY072Drug
Also called SPY002-072
Solution for SC injection
PlaceboDrug
Matching placebo for SC injection
bimekizumabDrug
Advanced standard of care
| Study group | Role | What they receive |
|---|---|---|
| SPY072 + bimekizumab | Experimental | Participants receive SPY072 + bimekizumab Receives: Drug: SPY072; Drug: bimekizumab |
| Placebo + bimekizumab | Placebo comparator | Participants receive matching placebo for SPY072 + bimekizumab Receives: Drug: Placebo; Drug: bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
Secondary outcomes (2)
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.
Measured: Week 16
Treatment-emergent Adverse Events (TEAEs)
Incidence, severity and causal relationship of TEAEs
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel treatment arms; SPY072 or matching placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spyre Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Friedman, MD, PhD, Study director, Spyre Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766005
- Sponsor's protocol ID
- SPY002-072-202
- Other IDs
- 2026-527868-32
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Assess the Efficacy and Safety of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa Receiving Standard of Care Treatment
- ClinicalTrials.gov ID
- NCT07766005
- Acronym / sponsor ID
- SPY002-072-202
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis suppurativa, Hidradenitis, Skin diseases, Sweat gland diseases, Skin and connective tissue diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spyre Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel treatment arms; SPY072 or matching placebo
| Arm | Type | Receives |
|---|---|---|
| SPY072 + bimekizumab | Experimental | Drug: SPY072, Drug: bimekizumabParticipants receive SPY072 + bimekizumab |
| Placebo + bimekizumab | Placebo comparator | Drug: Placebo, Drug: bimekizumabParticipants receive matching placebo for SPY072 + bimekizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPY072Also: SPY002-072Solution for SC injection | Drug | SPY072 + bimekizumab |
| PlaceboMatching placebo for SC injection | Drug | Placebo + bimekizumab |
| bimekizumabAdvanced standard of care | Drug | Placebo + bimekizumab, SPY072 + bimekizumab |
Primary outcome
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Time frame: 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
2 secondary outcomes
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time frame: Week 16
Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Friedman, MD, PhD study director
Spyre Therapeutics, Inc.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPY072 and bimekizumab in people with Hidradenitis Suppurativa (HS), run by Spyre Therapeutics, Inc. at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SKYLIGHT Trial Center (1-702-602-7976, info@SKYLIGHT-trial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.