A Study With CIT-013 in HS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CIT-013 high dose, CIT-013 medium dose, Placebo.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Germany, Netherlands, Poland, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa
Overview
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
Interventions
- Drug CIT-013 high dose
subcutaneous injection - Drug CIT-013 medium dose
subcutaneous injection - Drug Placebo
subcutaneous injection
Primary outcome measures
- Proportion of participants with HiSCR75 on CIT 013 versus placebo [Time frame: week 12]
Secondary outcome measures (2)
- Incidence of TEAEs as assessed by CTCAE [Time frame: week 12]
- Maximum Plasma Concentration of CIT-013 before doses [Time frame: 4, 6, 10 and 12 weeks]
Eligibility criteria
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
\- 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,
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 8 centers
- PL-06 — Bialystok
- PL-08 — Gdansk
- PL-03 — Katowice
- PL-02 — Lodz
- PL-10 — Lodz
- PL-09 — Poznan
- PL-01 — Rzeszów
- PL-05 — Wroclaw
Germany · 6 centers
- DE-06 — Bad Bentheim
- DE-01 — Bochum
- DE-04 — Dresden
- DE-02 — Frankfurt
- DE-08 — Kiel
- DE-03 — Oldenburg
Canada · 5 centers
- CA-01 — Barrie
- CA-05 — Calgary
- CA-02 — London
- CA-04 — Newmarket
- CA-03 — Winnipeg
Spain · 5 centers
- ES-05 — Barcelona
- ES-04 — Madrid
- ES-02 — Santiago de Compostela
- ES-03 — Seville
- ES-01 — Valencia
United Kingdom · 3 centers
- GB-02 — Cardiff
- GB-05 — Chester
- GB-04 — London
Netherlands · 1 center
- Erasmus UMC — Rotterdam
Identifiers
NCT: NCT06993233 · CITRYLL003