Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.

NCT04084665 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: JFR-0992
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hidradenitis Suppurativa (HS) is a severe, chronic debilitating disease with a variable and incomplete response to current treatments. Existing immunological studies have found dysregulation in the TH17:Treg axis with an increase in inflammatory mediators including TNFalpha, IL-17 IL-23 (amongst others) in lesional skin. Multiple cell typesincluding CD4+ cells, dendritic cells and macrophages infiltrate active lesions of HS and produce this major contribution from the Th17 axis. One of the main barriers to the development of novel and effective treatments for HS is the lack of biomarker(s) of disease activity, as well as our incomplete understanding of the pathogenesis of this disease. Given the pronounced contribution of Th17 pathway (including interleukin-23) in the inflammation in HS, further investigation into the role of this axis in the pathogenicity of HS is essential. Guselkumab is a fully human interluekin-23 antagonist, FDA approved for the treatment of moderate to severe psoriasis in participants 18 years and over. Guselkumab is a novel potential therapy.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (3)

• Biomarkers at Week 12

  Change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23, measured in pg/mL

  Week 12 compared with baseline (Week 0).

• Biomarkers at Week 24

  Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL

  Week 24 compared with baseline (Week 0).

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence of Grade 2/3 adverse events during the study

  Week 0 to Week 24

Secondary Outcomes (6)

• Clinical Response at Week 12 (as measured by HiSCR)

  Week 12 compared with Baseline

• Clinical Response at Week 12 (as measured by modified Sartorius Score)

  Week 12 compared with Baseline

• Clinical Response at Week 12 (as measured by IHS4)

  Week 12 compared with Baseline

• Clinical Response at Week 24 (as measured by HiSCR)

  Week 24 compared with Baseline

• Clinical Response at Week 24 (as measured by modified Sartorius Score)

  Week 24 compared with Baseline

Study Arms (1)

Intervention

EXPERIMENTAL

Guselkumab 200mg q4 weekly

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of medical history
• Have HS lesions present in at least 2 distinct anatomical areas
• Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had contraindications to oral antibiotic treatment of their HS
• Have a total abscess and inflammatory nodule (AN) count greater than or equal to 3 at the screening and baseline visit
• Must agree with daily use (throughout the study of one of the following over the counter treatments to body areas affected with HS lesions: either soap and water, a topical antiseptic was containing chlorhexidine gluconate, triclosan or benzoyl peroxide, or a dilute bleach bath.

You may not qualify if:

• HIV Positive
• Active Hepatitis B or C Infection
• Pregnant or Breastfeeding
• No concurrent use of any systemic antibiotics/retinoids/immunosuppressants (require washout period of 5 half lives)
• Any medical, psychological or social condition that, in the opinion of the investigator would jeopardize the health or well being of the participant during any study procedures or integrity of the data
• Has a draining fistula count greater than 20 at baseline visit Any other active skin disease (bacterial fungal or viral infection) that could have interfered with the assessment of HS

Sponsors & Collaborators

• Rockefeller University: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Rockefeller Unviersity

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• John W Frew, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Arm Open Label

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 10, 2019
• Study Start: June 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)