A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA

CONDITION

Skin

GENDER

Both males and females

AGE GROUP

From 18

and above

STATUS

Recruiting

Inclusion criteria*

To be eligible for enrolment in the study, all the following criteria must be met:

  • 18-75 years of age
  • Diagnosed (or recognisable symptoms consistent with a diagnosis) with moderate to severe HS for at least one year
  • HS lesions (Hurley Stage II-III) present in at least 2 distinct anatomic areas
  • Inadequate response to at least 28-days of oral antibiotic treatment for HS (unless oral antibiotic treatments are inadvisable due to important side effects or safety risks)
  • Body Mass Index ≥17.5 kg/m2 and body weight ≥40 kg

Selected exclusion criteria*

Participants are excluded from the study if any of the following criteria apply:

  • Evidence of other active skin condition that would interfere with the evaluation of HS
  • Any condition possibly affecting oral drug absorption
  • Current, or within past year, history of severe, progressive or uncontrolled renal,
    hepatic, haematological, GI or metabolic, endocrine, pulmonary, cardiovascular
    or neurological disease
  • History of any lymphoproliferative disorder
  • History of recurrent (≥2) venous thrombosis or any arterial thromboembolism or known
    blood clotting disorder
  • Malignancies or history of malignancies†

* Full inclusion/exclusion criteria and further study details are available on request.
† Certain malignancies permitted and further study details are available on request.

CONTACT DETAILS

Clinical Trial Site: The Skin Hospital (Skin & Cancer Foundation Australia)
Phone Number: (02) 8651 2027 Email: clinicaltrials@skinhospital.edu.au Location: 121 Crown Street, Darlinghurst NSW, Australia
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Approved By: Bellberry              

Clinical Trial Registry Link: Click Here