A Study With CIT-013 in HS Patients

NCT ID: NCT06993233

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Hidradenitis Suppurativa (HS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CIT-013 high dose

6 SC injections with CIT-013 high dose

Group Type EXPERIMENTAL

CIT-013 high dose

Intervention Type DRUG

subcutaneous injection

CIT-013 medium dose

6 SC injections with CIT-013 medium dose

Group Type EXPERIMENTAL

CIT-013 medium dose

Intervention Type DRUG

subcutaneous injection

Placebo

6 SC injections with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection

Interventions

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CIT-013 high dose

subcutaneous injection

Intervention Type DRUG

CIT-013 medium dose

subcutaneous injection

Intervention Type DRUG

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Citryll BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maarten Kraan

Role: STUDY_DIRECTOR

Citryll BV

Locations

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Erasmus UMC

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

GB-05

Chester, , United Kingdom

Site Status RECRUITING

Countries

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Netherlands United Kingdom

Central Contacts

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Leonie M Middelink

Role: CONTACT

+31613328444

Facility Contacts

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PI NL-01

Role: primary

PI UK-05

Role: primary

+44 0203 865 1142

Other Identifiers

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CITRYLL003

Identifier Type: -

Identifier Source: org_study_id

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