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NCT Number: NCT06993233

A Study With CIT-013 in HS Patients

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CA-01, Barrie, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Any other systemic therapy for HS (28 days before baseline)
  • 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,

Treatment and study plan

CIT-013 high dose

Drug

subcutaneous injection

CIT-013 medium dose

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Proportion of participants with HiSCR75 on CIT 013 versus placebo

    Time frame: week 12

Secondary outcomes

  1. Incidence of TEAEs as assessed by CTCAE

    Time frame: week 12

  2. Maximum Plasma Concentration of CIT-013 before doses

    Time frame: 4, 6, 10 and 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Leonie M Middelink

CONTACT

[email protected]

+31613328444

Sponsors and collaborators

Lead sponsor

Citryll BV

Industry

Registry information

Official study 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

Acronym: Citylights

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 28, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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