Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2025-10-31
2027-07-31
Brief Summary
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Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS.
Participants will:
Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CIT-013 high dose
6 SC injections with CIT-013 high dose
CIT-013 high dose
subcutaneous injection
CIT-013 medium dose
6 SC injections with CIT-013 medium dose
CIT-013 medium dose
subcutaneous injection
Placebo
6 SC injections with placebo
Placebo
subcutaneous injection
Interventions
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CIT-013 high dose
subcutaneous injection
CIT-013 medium dose
subcutaneous injection
Placebo
subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 18 years of age at screening visit,
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),
* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,
* Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,
* Total draining tunnel count less than 20
Exclusion Criteria
* Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
* Prior treatment with any of the following medications before baseline:
1. Any other systemic therapy for HS (28 days before baseline)
2. Any IV anti-infective therapy (14 days before baseline)
* History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,
18 Years
ALL
No
Sponsors
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Citryll BV
INDUSTRY
Responsible Party
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Principal Investigators
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Maarten Kraan
Role: STUDY_DIRECTOR
Citryll BV
Locations
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Erasmus UMC
Rotterdam, , Netherlands
GB-05
Chester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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PI NL-01
Role: primary
Other Identifiers
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CITRYLL003
Identifier Type: -
Identifier Source: org_study_id
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