The objective of this study is to assess the safety and efficacy of 2 dose levels of risankizumab versus placebo for the treatment of signs and symptoms of moderate to severe Hidradentitis Supperativa in adult subjects diagnosed for at least one…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of subjects achieving Hidradenitis
Suppurativa Clinical Response (HiSCR) at Week 16. HiSCR is defined as at least
a 50% reduction in the total inflammatory nodule [AN] count with no increase in
abscess count and no increase in draining fistula count relative to baseline.
Secondary outcome
Proportion of subjects achieving at least 30% reduction and at least 1 unit
reduction from Baseline in NRS30 in PGA Skin Pain at Week 8 among subjects with
Baseline Numerical Rating Scale (NRS) >= 3.
Proportion of subjects achieving NRS30 in PGA Skin Pain at Week 16 among
subjects with Baseline NRS >= 3.
Proportion of subjects who experience at least 25% increase in AN counts with a
minimum increase of 2 relative to Baseline during Period A.
Change from Baseline in DLQI at Week 16.
Change from Baseline in HS-related swelling - assessed based on the
HSSA at Week 16.
Change from Baseline in HS-related odor - assessed based on the HSSA
at Week 16.
Change from Baseline in HS-related worst drainage - assessed based on
the HSSA at Week 16.
Background summary
Hidradenitis suppurativa (HS) is an inflammatory, debilitating skin disease
with a characteristic clinical presentation of recurrent or chronic painful or
suppurating lesions that most commonly present in
the axilla, inguinal, and anogenital regions.
This study will provide essential data for risankizumab registration as
treatment for patients
with moderate to severe HS, as there is still a high unmet need for new safe
and efficacious HS therapies.
The primary hypothesis for the study is that risankizumab will provide superior
efficacy compared to placebo and will be well tolerated in subjects with
Hidradentitis Supperativa.
Study objective
The objective of this study is to assess the safety and efficacy of 2 dose
levels of risankizumab versus placebo for the treatment of signs and symptoms
of moderate to severe Hidradentitis Supperativa in adult subjects diagnosed for
at least one year before the Baseline visit.
Study design
This is a phase-2 multi-center, randomized, double-blinded, parallel-group,
placebo-controlled study to evaluate the safety and efficacy of 2 dose levels
of risankizumab in adult subjects with moderate to severe HS diagnosed at least
1 year before Baseline Visit. The study compromises a 35*day screening period,
and a 68-week study period. The follow*up period consists of a follow*up phone
call 20 weeks after the last study drug dose.
The study is designed to enroll 220 subjects worldwide.
Intervention
This study includes two treatment periods. Eligible Subjects will be randomized
to receive risankizumab or placebo in a 1:1:1 ratio:
Period A (16 weeks):
Subjects will receive risankizuamb or placebo until Week 12 visit:
• Risankizumab subcutaneous (SC) injection (dose A) ; OR
• Risankizumab subcutaneous (SC) injection (dose B) ; OR
• Placebo subcutaneous (SC) injection
Period B (52 weeks):
At Weeks 16, 17, 18, subjects initially randomized to the placebo arm will
receive blinded risankizumab. Patients who were initially randomized to the
risankizumab arm will receive blinded matching placebo. Starting from week 20
all subjects will receive open-label risankizumab.
Risankizumab and placebo will be administrated subcutaneously with pre-filled
syringes.
Study burden and risks
There is a higher burden for subjects participating in this study compared to
receiving standard medical care. Subjects will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling and questionnaires. Subjects will also be tested for
tuberculosis (TB), hepatitis B (HBV), hepatitis C (HCV), and human
immunodeficiency virus (HIV). Women of childbearing potential are required to
practice a method of birth control both during the study and through 20 weeks
after the last dose of study drug and are tested for pregnancy during the study.
The most common side effects reported during previous studies of risankizumab
were upper respiratory infections, feeling tired, fungal skin infection,
injection site reactions and headache.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
• Subjects must be >= 18 years old at Screening with a clinical diagnosis
of moderate to severe HS (defined as a total AN count of >= 5 at Baseline,
presence of HS lesions in at least 2 distinct anatomic areas, and draining
fistula count of <= 20 at Baseline) for at least 1 year prior to Baseline, as
determined by the investigator (i.e., through medical history, interview
of subject).
• Subjects must have a history of inadequate response or intolerance to
an adequate trial of oral antibiotics for treatment of HS.
• Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the
study population)
• Prior exposure to anti-TNF (overall, no more than 15% of the study
population)
Exclusion criteria
No history of active skin disease other than HS that could interfere with
the assessment of HS.
No active TB or concurrent treatment for latent TB and no evidence of
HBV, HCV or HIV.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000122-21-NL |
| ClinicalTrials.gov | NCT03926169 |
| CCMO | NL69816.078.19 |