A Study With CIT-013 in HS Patients

Phase 2

Not yet recruiting

• Conditions: Hidradenitis Suppurativa (HS)
• Interventions: Drug: CIT-013 high dose; Drug: CIT-013 medium dose; Drug: Placebo

• Registration Number: NCT06993233
• Lead Sponsor: Citryll BV

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Study First Posted: 2025-05-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-01
• Primary Completion: 2027-04
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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

• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIT-013 high dose	CIT-013 high dose	6 SC injections with CIT-013 high dose
CIT-013 medium dose	CIT-013 medium dose	6 SC injections with CIT-013 medium dose
Placebo	Placebo	6 SC injections with placebo

Primary Outcome Measures

Name	Time	Method
Proportion of participants with HiSCR75 on CIT 013 versus placebo	week 12

Secondary Outcome Measures

Name	Time	Method
Incidence of TEAEs as assessed by CTCAE	week 12
Maximum Plasma Concentration of CIT-013 before doses	4, 6, 10 and 12 weeks

Trial Locations

Locations (1)

Erasmus UMC; 🇳🇱 Rotterdam, Netherlands