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A Study With CIT-013 in HS Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study With CIT-013 in HS Patients

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

NCT06993233•Citryll BV

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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,

Locations (24)

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

Key Dates

Start Date

October 31, 2025

Primary Completion Date

April 1, 2027

Completion Date

July 1, 2027

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Hidradenitis Suppurativa (HS)

Interventions

CIT-013 high dose

DRUG

CIT-013 medium dose

DRUG

Placebo

DRUG

Contacts

Leonie M Middelink

CONTACT

+31613328444 lmiddelink@citryll.com

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Hidradenitis Suppurativa (HS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study With CIT-013 in HS Patients

Inclusion Criteria

Exclusion Criteria

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

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