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Active, not recruitingPhase 2

A Study With CIT-013 in HS Patients

Key facts

Who runs it
Citryll BV
Where
Canada, Germany, Netherlands, Poland, Spain, and United Kingdom29 sites in 6 countriesChoose a country to see its sites
Status
Active, not recruiting
Phase
Phase 2
People taking part
108 people enrolled
Started
31 Oct 2025
Expected to end
Jul 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • CIT-013 high dose
  • CIT-013 medium dose
  • Placebo
Record updated
19 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
  • Prior treatment with any of the following medications before baseline:; Any other systemic therapy for HS (28 days before baseline); Any IV anti-infective therapy (14 days before baseline)
  • 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,
  • History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,

This trial has no sites in United States.

It has sites in 6 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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

The 3 groups in the trial

  • CIT-013 high doseTreatment being tested

    6 SC injections with CIT-013 high dose

  • CIT-013 medium doseTreatment being tested

    6 SC injections with CIT-013 medium dose

  • PlaceboPlacebo, for comparison

    6 SC injections with placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa
Record updated
19 October 2026