Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Hidradenitis Suppurativa, Palmoplantar Pustulosis|
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
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.