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Active, not recruiting Phase 2

A Study With CIT-013 in HS Patients

NCT06993233 · tracked via the Priya Life Science UK tracker
Sponsor
Citryll BV
Phase
Phase 2
Started
2025-10-31
Last updated
2026-10-19

Condition(s) studied

Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

CIT-013 high doseCIT-013 medium dosePlacebo

CIT-013 high dose: subcutaneous injection

CIT-013 medium dose: subcutaneous injection

Placebo: subcutaneous injection

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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,

Primary outcome measure(s)

  • Proportion of participants with HiSCR75 on CIT 013 versus placebo — week 12

Trial sites (28)

FacilityCityRegionStatus
CA-01 Barrie Canada
CA-05 Calgary Canada
CA-02 London Canada
CA-04 Newmarket Canada
CA-03 Winnipeg Canada
DE-06 Bad Bentheim Germany
DE-01 Bochum Germany
DE-04 Dresden Germany
DE-02 Frankfurt Germany
DE-08 Kiel Germany
DE-03 Oldenburg Germany
Erasmus UMC Rotterdam Netherlands
PL-06 Bialystok Poland
PL-08 Gdansk Poland
PL-03 Katowice Poland
PL-02 Lodz Poland
PL-10 Lodz Poland
PL-09 Poznan Poland
PL-01 Rzeszów Poland
PL-05 Wroclaw Poland
ES-05 Barcelona Spain
ES-04 Madrid Spain
ES-02 Santiago de Compostela Spain
ES-03 Seville Spain
ES-01 Valencia Spain
GB-02 Cardiff United Kingdom
GB-05 Chester United Kingdom
GB-04 London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06993233 on ClinicalTrials.gov ↗ ← All trials in the UK