NCT06993233 A Study With CIT-013 in HS Patients
| NCT ID | NCT06993233 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Citryll BV |
| Condition | Hidradenitis Suppurativa (HS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 96 participants in total. It began in 2025-10-31 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: 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
Eligibility Criteria
Inclusion Criteria: * Male or female participants with HS of more than 6 months duration, * 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: \- Participants for whom an approved therapy with demonstrated clinical benefit is indicated, available and expected to be tolerated, OR choose to proceed with standard of care treatment options over the IP (after being appropriately informed of the treatment options, risks, and benefits). Any current and/or recurrent clinically significant skin condition in the treatment area other than HS, * 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,
Contact & Investigator
Maarten Kraan
STUDY DIRECTOR
Citryll BV
Frequently Asked Questions
Who can join the NCT06993233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hidradenitis Suppurativa (HS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06993233 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06993233 currently recruiting?
Yes, NCT06993233 is actively recruiting participants. Contact the research team at lmiddelink@citryll.com for enrollment information.
Where is the NCT06993233 trial being conducted?
This trial is being conducted at Barrie, Canada, Calgary, Canada, London, Canada, Newmarket, Canada and 11 additional locations.
Who is sponsoring the NCT06993233 clinical trial?
NCT06993233 is sponsored by Citryll BV. The principal investigator is Maarten Kraan at Citryll BV. The trial plans to enroll 96 participants.