Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06993233

A Phase 2a Double Blind, Randomized, Placebo-Controlled Trial Evaluating Two Dose Levels of CIT-013 for Hidradenitis Suppurativa

Led by Citryll BV · Updated on 2026-05-22

96

Participants Needed

28

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of CIT-013 in adults with Hidradenitis Suppurativa (HS), a chronic skin condition. This Phase 2a randomized, double-blind, placebo-controlled trial aims to find out if CIT-013 can reduce disease activity and to assess its safety. The study compares two doses of CIT-013 to a placebo to understand its impact on symptoms and medical issues experienced by participants. Participants will receive either a high dose (100 mg) or medium dose (50 mg) of CIT-013, or a placebo, through subcutaneous injections every other week for 12 weeks. The treatments involve six injections in total. The trial includes three groups: one for each dose of CIT-013 and one for the placebo, all administered via injections under the skin. During the study, participants will visit the clinic every two weeks for checkups and tests. Researchers will monitor symptoms, measure disease activity using the HiSCR75 response at week 12, and track any treatment-related adverse events. Blood samples will be taken at various points to assess drug levels. The total study participation lasts for 12 weeks with regular monitoring throughout this period.

CONDITIONS

Brief Title

A Study With CIT-013 in HS Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants with Hidradenitis Suppurativa lasting more than 6 months
  • At least 18 years old at screening
  • HS lesions in two or more distinct body areas, with at least one area classified as Hurley Stage II or III
  • Total count of abscesses and inflammatory nodules of 5 or more at screening and before enrollment
  • Inadequate response to, recurrence after stopping, intolerance to, or contraindication for oral antibiotics for HS
  • Total draining tunnel count less than 20
Not Eligible

You will not qualify if you...

  • Participants who have approved therapies with clinical benefit available and plan to use standard care instead of the study treatment
  • Presence of other significant skin conditions in treatment areas besides HS
  • Treatment with recombinant therapeutic proteins within 6 weeks before baseline
  • Use of systemic HS therapies within 28 days before baseline
  • Use of intravenous anti-infective therapy within 14 days before baseline
  • History of cancer except treated and cured non-melanoma skin cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants receive 6 subcutaneous injections of either CIT-013 high dose, CIT-013 medium dose, or placebo.

6 visits for injections

Trial Site Locations

Total: 28 locations

1

CA-01

Barrie, Canada

Actively Recruiting

2

CA-05

Calgary, Canada

Actively Recruiting

3

CA-02

London, Canada

Actively Recruiting

4

CA-04

Newmarket, Canada

Actively Recruiting

5

CA-03

Winnipeg, Canada

Actively Recruiting

6

DE-06

Bad Bentheim, Germany

Actively Recruiting

7

DE-01

Bochum, Germany

Actively Recruiting

8

DE-04

Dresden, Germany

Actively Recruiting

9

DE-02

Frankfurt, Germany

Actively Recruiting

10

DE-08

Kiel, Germany

Actively Recruiting

11

DE-03

Oldenburg, Germany

Actively Recruiting

12

Erasmus UMC

Rotterdam, Netherlands

Actively Recruiting

13

PL-06

Bialystok, Poland

Actively Recruiting

14

PL-08

Gdansk, Poland

Actively Recruiting

15

PL-03

Katowice, Poland

Actively Recruiting

16

PL-02

Lodz, Poland

Not Yet Recruiting

17

PL-10

Lodz, Poland

Actively Recruiting

18

PL-09

Poznan, Poland

Actively Recruiting

19

PL-01

Rzeszów, Poland

Actively Recruiting

20

PL-05

Wroclaw, Poland

Actively Recruiting

21

ES-05

Barcelona, Spain

Not Yet Recruiting

22

ES-04

Madrid, Spain

Not Yet Recruiting

23

ES-02

Santiago de Compostela, Spain

Not Yet Recruiting

24

ES-03

Seville, Spain

Not Yet Recruiting

25

ES-01

Valencia, Spain

Actively Recruiting

26

GB-02

Cardiff, United Kingdom

Actively Recruiting

27

GB-05

Chester, United Kingdom

Actively Recruiting

28

GB-04

London, United Kingdom

Actively Recruiting

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Research Team

L

Leonie M Middelink

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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