A Study With CIT-013 in HS Patients

NCT06993233 | Recruiting Phase 2

• 1 other identifier: CITRYLL003
• Study Type: interventional
• Target: 96
• Locations: 6 countries
• Sites: 24

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)

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with HiSCR75 on CIT 013 versus placebo

  week 12

Secondary Outcomes (2)

• Incidence of TEAEs as assessed by CTCAE

  week 12

• Maximum Plasma Concentration of CIT-013 before doses

  4, 6, 10 and 12 weeks

Study Arms (3)

CIT-013 high dose

EXPERIMENTAL

6 SC injections with CIT-013 high dose

Drug: CIT-013 high dose

CIT-013 medium dose

EXPERIMENTAL

6 SC injections with CIT-013 medium dose

Drug: CIT-013 medium dose

Placebo

PLACEBO COMPARATOR

6 SC injections with placebo

Drug: Placebo

Interventions

CIT-013 high dose DRUG

subcutaneous injection

CIT-013 high dose

CIT-013 medium dose DRUG

subcutaneous injection

CIT-013 medium dose

Placebo DRUG

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants with HS of more than 6 months duration,
• 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

You may not qualify if:

• \- 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:
• Any other systemic therapy for HS (28 days before baseline)
• 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,

Sponsors & Collaborators

• Citryll BV: lead

Study Sites (24)

CA-01

Barrie, Canada

RECRUITING

CA-05

Calgary, Canada

RECRUITING

CA-02

London, Canada

RECRUITING

CA-04

Newmarket, Canada

RECRUITING

CA-03

Winnipeg, Canada

RECRUITING

DE-06

Bad Bentheim, Germany

RECRUITING

DE-01

Bochum, Germany

RECRUITING

DE-04

Dresden, Germany

RECRUITING

DE-02

Frankfurt, Germany

RECRUITING

DE-08

Kiel, Germany

RECRUITING

DE-03

Oldenburg, Germany

NOT YET RECRUITING

Erasmus UMC

Rotterdam, Netherlands

RECRUITING

PL-03

Katowice, Poland

RECRUITING

PL-02

Lodz, Poland

NOT YET RECRUITING

PL-01

Rzeszów, Poland

RECRUITING

PL-05

Wroclaw, Poland

RECRUITING

ES-05

Barcelona, Spain

NOT YET RECRUITING

ES-04

Madrid, Spain

NOT YET RECRUITING

ES-02

Santiago de Compostela, Spain

NOT YET RECRUITING

ES-03

Seville, Spain

NOT YET RECRUITING

ES-01

Valencia, Spain

NOT YET RECRUITING

GB-02

Cardiff, United Kingdom

NOT YET RECRUITING

GB-05

Chester, United Kingdom

RECRUITING

GB-04

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Maarten Kraan

  Citryll BV

  STUDY DIRECTOR

Central Study Contacts

Leonie M Middelink

CONTACT

+31613328444; lmiddelink@citryll.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-11

Locations

PL (4); NL (1); GB (3); ES (5); DE (6); CA (5)