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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.
"

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03972280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CSL Behring
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hidradenitis Suppurativa, Palmoplantar Pustulosis
Arms & Interventions

Arms

Experimental: Dose Level 1 (HS)

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

Experimental: Dose Level 1 (PPP)

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

Experimental: Dose Level 1 (Total)

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

Experimental: Dose Level 2 (HS)

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

Experimental: Dose Level 2 (PPP)

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

Experimental: Dose Level 2 (Total)

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

Interventions

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

Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fremantle Dermatology, Fremantle, Australia

Status

Recruiting

Address

Fremantle Dermatology

Fremantle, ,

The Royal Melbourne Hospital, Parkville, Australia

Status

Recruiting

Address

The Royal Melbourne Hospital

Parkville, ,

Westmead Hospital, Westmead, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.