Recruiting

Phase 2

CIT-013A Study With CIT-013 in HS Patients

Sponsor:

Citryll BV

Code:

NCT06993233

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CIT-013 high dose

CIT-013 medium dose

Placebo

Study Details

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

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT06993233

Start date

Oct 31, 2025

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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,

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CIT-013 high dose

6 SC injections with CIT-013 high dose

experimental: CIT-013 medium dose

6 SC injections with CIT-013 medium dose

placebo comparator: Placebo

6 SC injections with placebo

Interventions

CIT-013 high dose

subcutaneous injection

CIT-013 medium dose

subcutaneous injection

Placebo

subcutaneous injection

Primary outcome measure

Proportion of participants with HiSCR75 on CIT 013 versus placebo [ Time Frame: week 12 ]

Central Contacts and Locations

Central contacts

Leonie M Middelink

+31613328444 lmiddelink@citryll.com

Locations

CA-01

Recruiting

Barrie, Canada

CA-05

Recruiting

Calgary, Canada

CA-02

Recruiting

London, Canada

CA-04

Recruiting

Newmarket, Canada

CA-03

Recruiting

Winnipeg, Canada

More Information

Sponsor

Citryll BV

Last update posted

May 22, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Citryll BV on 2026-05-22.