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ClinicalTrials.gov ID

NCT06993233

Lead Sponsor

Citryll BVINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

96Estimated

Last Update Posted

May 22, 2026Actual

Start Date

Oct 31, 2025Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

Jul 2027Estimated

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

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

• Hidradenitis Suppurativa (HS)

• CIT-013 high dose
• CIT-013 medium dose
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Citryll BVINDUSTRY

lmiddelink@citryll.com+44 0203 865 1142