Hidradenitis Suppurativa

Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis

NCT03972280 | PHASE 1 | INTERVENTIONAL

Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.

11 Sites

39 Participants

Recruiting

18 Years to 75 Years

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SUBMIT

Holdsworth House Medical Practice

Darlinghurst,Australia,2010

Fremantle Dermatology

Fremantle,Australia,6160

The Royal Melbourne Hospital

Parkville,Australia,3052

Westmead Hospital

Westmead,Australia,2145

Bispebjerg Hospital

Copenhagen,Denmark,2400

Gentofte Hospital

Hellerup,Denmark,2900

Zealand University Hospital

Roskilde,Denmark,4000

Charit Universittsmedizin Berlin

Berlin,Germany,10117

St. Josef Hospital

Bochum,Germany,44791

Klinikum Darmstadt

Darmstadt,Germany,64283

Universittsklinikum Carl Gustav Carus

Dresden,Germany,01307

Study Eligibility Criteria

Inclusion Criteria

* Male or female subjects between 18 and 75 years of age, inclusive
* Confirmed clinical diagnosis of moderate to severe HS as per International Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 ≥ 4)
* PPP differentiated from other forms of pustulosis
* Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) score of ≥ 12.
* Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of HS
* Subjects with PPP only: confirmed clinical diagnosis of PPP at least 6 months before Screening and inadequate response to topical therapy, phototherapy, and / or previous systemic therapy for the treatment of PPP

Exclusion Criteria

* Treatment with any medications and therapies not permitted during the study.
* History of myeloproliferative disease.
* Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
* Current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis B virus and / or hepatitis C virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the Investigator and / or Sponsor.
* Congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection.
* Clinical signs of active infection and / or fever \> 38°C during the 7 days before Day 1.
* Clinically significant abnormalities on physical examination, ECG, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \< 2.0 × 109/L) at Screening.
* Subjects with PPP only: concurrent psoriasis vulgaris (not including scaly scalp and / or ears).
* Subjects with HS only: \> 20 draining fistulas."

Additional Studies

Additional studies can be found at ClinicalTrials.gov