Actively Recruiting
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
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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
Eligibility Criteria
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
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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