A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

Phase 2

Completed

Conditions: 10014982
chronical pain
depression

Registration Number: NL-OMON46316

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

-Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
-Have moderate to severe HS for at least 1 year (365 days) prior to the baseline visit.
-Have HS lesions present in at least 2 distinct anatomic areas.
-Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
-Have stable HS for at least 1 month (28 days) prior to the screening visit.
-Have a total abscess and inflammatory nodule (AN) count of *3 at the screening and baseline visit.
-Must agree to daily use of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath.
-Before randomization, a woman must be either:
a. not of childbearing potential;
b. of childbearing potential and practicing a highly effective method of birth control.
-A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 prior to administration of study intervention.
-A woman must agree not to donate eggs for the purposes of assisted reproduction during the study and for at least 12 weeks after receiving the last administration of study intervention.
-A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control.
-Are considered eligible according to the following TB screening criteria:
a. have no history of latent or active TB before screening;
b. have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
c. have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study intervention;
d. within 2 months before the first administration of study intervention, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON®-TB test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study intervention;
e. have a chest radiograph (both posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of study intervention and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
-Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
-Agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study intervention.
-Have screening laboratory test results within the following parameters:
a. Hemoglobin *10 g/dL
b. White blood cells *3.5 x 103/µL
c. Neutrophils *1.5 x 103/µL
d. Platelets *100 x 103/µL
e. Serum creatinine *1.5 mg/dL
f. Aspartate aminotransferase *2 × upper limit of normal (ULN)
g. Alanine aminotransferase *2 × ULN
h. Alkaline phosphatase *2 × ULN
-Be willing and able to adhere to the prohibitions and restrictions

Exclusion Criteria

-Has previously received guselkumab.
-Any other active skin disease or condition that could have interfered with assessment of HS.
-Has a draining fistula count of >20 at the baseline visit.
-Receipt of immunomodulatory biologic therapies (eg monoclonal antibodies) within 3 months or 5 half-lives prior to the baseline visit, whichever is longer.
-Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 weeks prior to the baseline visit.
-Receipt of systemic non-biologic therapies for the treatment of HS <4 weeks prior to the baseline visit.
-Has received any therapeutic agent directly targeted to IL-17 or IL-23 within 6 months of the first administration of study intervention (including but not limited to ustekinumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, or brodalumab).
-Has received natalizumab, belimumab, or agents that modulate B cells or T cells (eg, rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study intervention.
-Has received any systemic immunosuppressants (eg, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus) or anakinra within 4 weeks of the first administration of study intervention.
-Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
-Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months.
-Currently has a malignancy or has a history of malignancy within 5 years before screening.
-Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening.;For a complete list of all exclusion criteria, please refer to section 5.2 of the protocol on page 26-30.