Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CIT-013 high dose

    Drug

    subcutaneous injection

  • CIT-013 medium dose

    Drug

    subcutaneous injection

  • Placebo

    Drug

    subcutaneous injection

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: CIT-013 high doseExperimental treatment 1 intervention
Group B: CIT-013 medium doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with HiSCR75 on CIT 013 versus placebo

Time frame
week 12

Secondary outcomes

1

Incidence of TEAEs as assessed by CTCAE

Time frame
week 12
2

Maximum Plasma Concentration of CIT-013 before doses

Time frame
4, 6, 10 and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Citryll BV

Lead sponsor

Source ClinicalTrials.gov
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