Phase 2
N=181
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT03628924 ↗Enrolled (actual)
181
Serious AEs
3.7%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 — 38.7; 50.8; 45.0 percentage of participants — p== 0.166
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Guselkumab dose 1 (Drug); Guselkumab dose 2 (Drug); Guselkumab dose 3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 |
38.7; 50.8; 45.0 | = 0.166 |
| SECONDARY Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16 |
-3.2; -5.3; -5.3 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
-0.7; -3.4; -2.5 | — |
| SECONDARY Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16 |
-0.3; -1.6; -1.2 | — |
| SECONDARY Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 |
45.2; 55.9; 51.7 | — |
| SECONDARY Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 |
30.6; 40.7; 26.7 | — |
| SECONDARY Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 |
17.7; 22.0; 15.0 | — |
| SECONDARY Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 |
14.5; 15.3; 15.0 | — |
| SECONDARY Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16 |
27.4; 30.5; 23.3; 33.9; 39.0; 31.7 | — |
| SECONDARY Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0 |
39.3; 63.9; 45.2 | — |
| SECONDARY Change From Baseline in the Number of Abscesses at Week 16 |
-0.4; -2.1; -1.6 | — |
| SECONDARY Change From Baseline in HSSD Symptom Scale Total Score at Week 16 |
-0.19; -1.71; -0.82 | — |
| SECONDARY Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16 |
-0.4; -2.1; -1.3; 0.1; -1.6; -0.2 | — |
| SECONDARY Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0 |
36.6; 31.0; 20.5 | — |
| SECONDARY Change From Baseline in Number of Draining Fistulas at Week 16 |
-0.5; -1.7; -0.8 | — |
| SECONDARY Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0 |
17.7; 17.2; 18.6 | — |
| SECONDARY Change From Baseline in Number of Inflammatory Nodules at Week 16 |
-2.8; -3.2; -3.7 | — |
| SECONDARY Percentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16 |
16.1; 13.6; 13.3; 24.2; 28.8; 23.3 | — |
| SECONDARY Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline |
27.3; 32.7; 25.0 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16 |
0.0; 0.0; -0.3; 0.2; -0.6; -0.5 | — |
| SECONDARY Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16 |
-0.308; 3.238; -2.828 | — |
| SECONDARY Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16 |
4; 13; 10; 7; 14; 11 | — |
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).
Eligibility Criteria
Inclusion Criteria
- 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 the medical history
- Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold)
- Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigator's opinion
- Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 3 at the screening and baseline visit
- Must agree to daily use (throughout the entirety of the study) 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
Exclusion Criteria
- Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS
- Has a draining fistula count of greater than (>) 20 at the baseline visit
- Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit
- Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4 Weeks prior to the baseline visit
- Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit
Data sourced from ClinicalTrials.gov (NCT03628924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.