Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, acne inversa, platform study
Brief summary
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
Detailed description
This is a randomized, subject and investigator-blinded, placebo-controlled, multi-center and parallel-group non-confirmatory study to assess the efficacy, safety and tolerability of five investigational drugs, CFZ533 (iscalimab), LYS006, MAS825, LOU064 (remibrutinib) and VAY736 (ianalumab) in subjects with moderate to severe hidradenitis suppurativa. All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period. All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.
Interventions
DRUGCFZ533
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
DRUGPlacebo to CFZ533
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
DRUGLYS006
LYS006 20 mg administered orally twice per day until Week 16.
DRUGPlacebo to LYS006
Placebo administered orally twice per day until Week 16.
DRUGMAS825
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
DRUGPlacebo to MAS825
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
DRUGLOU064 25mg
LOU064 25 mg administered orally twice per day until Week 16.
DRUGLOU064 100mg
LOU064 100 mg administered orally twice per day until Week 16.
DRUGPlacebo to LOU064
Placebo administered orally twice per day until Week 16.
DRUGVAY736
VAY736 300 mg administered s.c every 4 weeks until Week 13.
Placebo administered s.c every 4 weeks until Week 13.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved * Minimal body weight of 50 kg * Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule
Exclusion criteria
* Use of other investigational drugs at the time of screening or before * Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception * Pregnant or lactating women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Baseline, Week 16 | sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included. |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Iceland, Netherlands, Spain, United States
Participant flow
Recruitment details
Participants took part in 36 investigative sites in 11 countries.
Pre-assignment details
The study consisted of a screening period of up to 35 days. After last dose of study treatment patients could enter the post-treatment follow-up.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 8.68 |
| Race/Ethnicity, Customized Asian Asian | 1 Participants |
| Race/Ethnicity, Customized Asian Black Or African American | 1 Participants |
| Race/Ethnicity, Customized Asian Other | 9 Participants |
| Race/Ethnicity, Customized Asian Unknown | 0 Participants |
| Race/Ethnicity, Customized Asian White | 13 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 27 | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 32 | 0 / 61 | 0 / 248 |
| other Total, other adverse events | 23 / 29 | 19 / 27 | 22 / 33 | 26 / 33 | 15 / 33 | 18 / 32 | 38 / 61 | 161 / 248 |
| serious Total, serious adverse events | 4 / 29 | 2 / 27 | 1 / 33 | 1 / 33 | 1 / 33 | 1 / 32 | 1 / 61 | 11 / 248 |
Outcome results
None listed