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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
subcutaneous injection
subcutaneous injection
subcutaneous injection
CA-01
Barrie, Canada
RECRUITINGCA-05
Calgary, Canada
NOT_YET_RECRUITINGCA-02
London, Canada
NOT_YET_RECRUITINGCA-04
Newmarket, Canada
NOT_YET_RECRUITINGCA-03
Winnipeg, Canada
RECRUITINGDE-06
Bad Bentheim, Germany
NOT_YET_RECRUITINGDE-01
Bochum, Germany
NOT_YET_RECRUITINGDE-04
Dresden, Germany
NOT_YET_RECRUITINGDE-02
Frankfurt, Germany
NOT_YET_RECRUITINGDE-08
Kiel, Germany
RECRUITING...and 14 more locations
Proportion of participants with HiSCR75 on CIT 013 versus placebo
Time frame: week 12
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
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