chronical pain depression
Conditions
Interventions
All participants will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups
as described below:
Group 1: Guselkumab Regimen 1 (1,200 mg IV q4w x 3 * 200 mg SC q4w)
Participants will receive guse
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Secondary Endpoints * The change from baseline in total abscess and inflammatory nodule (AN) count at Week 16. * The change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16. * The change from baseline in HS-related pain in the past 24 hours based on Hidradenitis Suppurativa Symptom Diary (HSSD) at Week 16. Other Secondary Endpoints * The proportion of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count at Week 16. * The proportion of participants achieving an AN count of 1 and 2, respectively, at Week 16. * The proportion of participants achieving complete elimination of abscesses at Week 16 among those participants with abscesses at baseline. * The change from baseline in the number of abscesses at Week 16. * The change from baseline in HSSD symptom scale score (other than pain the past 24 hours) at Week 16. * The change from baseline in HSSD total symptom score at Week 16. * The proportion of participants achieving complete elimination of draining fistulas at Week 16 among those participants with draining fistulas at baseline. * The change from baseline in number of draining fistulas at Week 16. * The proportion of participants achieving complete elimination of inflammatory nodules at Week 16 among those participants with inflammatory nodules at baseline. * The change from baseline in number of inflammatory nodules at Week 16. * The proportion of participants with HS-IGA (investigator*s global assessment) score of inactive (0), almost inactive (1), or mild (2) and with at least 2-grade improvement relative to baseline at Week 16. * The proportion of participants with HS-IGA score of inactive (0) or almost inactive (1) at Week 16 among participants with HS-IGA score of moderate (3) or severe (4) at baseline. * The change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 16. * The change from baseline in high-sensitivity C-reactive protein (hs-CRP | — |
Countries
Netherlands
Outcome results
None listed