A Study With CIT-013 in HS Patients
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCitryll BV
About this trial
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
Eligibility criteria
Qualifiers
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,
Disqualifiers
Prior treatment with a recombinant therapeutic protein during the 6 weeks 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,
Trial design
Treatments tested in this trial
- CIT-013 high dose
- CIT-013 medium dose
- Placebo
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov