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

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Palmoplantar Pustulosis; Hidradenitis Suppurativa

Treatments: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT03972280

CSL324_1002

2018-002871-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 6 patient groups

Dose Level 1 (HS)

Experimental group

Description:

Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Dose Level 1 (PPP)

Experimental group

Description:

Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Dose Level 1 (Total)

Experimental group

Description:

Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Dose Level 2 (HS)

Experimental group

Description:

Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Dose Level 2 (PPP)

Experimental group

Description:

Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Dose Level 2 (Total)

Experimental group

Description:

Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP

Treatment:

Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody