Hidradenitis Suppurativa (HS)
Conditions
Keywords
Moderate to severe hidradenitis suppurativa (HS), IL-17A, monoclonal antibody, AIN457, secukinumab, HiSCR, pain, efficacy, safety
Brief summary
This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).
Detailed description
The study consists of a Screening period (at least 7 days and up to 4 weeks), Treatment Period 1 (16 weeks), Treatment Period 2 (36 weeks), and a post-treatment Follow-up period (10 or 12 weeks depending on dose regimens). Total duration of the study is up to 66 weeks. Screening period: A screening period of at least 7 days and up to 4 weeks will be used to assess the participant´s eligibility, to complete 7-day Pain NRS and to washout and/or taper prohibited medication(s). Treatment Period 1: All participants will be administered subcutaneous (s.c.) injections of secukinumab 300 mg once a week for five weeks (induction) at Baseline, Weeks 1, 2, 3 and 4. Thereafter, the frequency of study drug injections will be every 4 weeks for all participants up to Week 16. Treatment Period 2: Starting from Week 16, participants can continue secukinumab 300 mg Q4W dosing until Week 48 or switch to secukinumab 300 mg Q2W, until Week 50 based on investigator's judgement at Week 16. Follow-up period: Participants who prematurely discontinue study treatment in Treatment Periods 1 or 2 for any reason will enter the Post-Treatment Follow-Up period and complete the EOS visit (12 weeks after the last administration of study treatment).
Interventions
DRUGSecukinumab
secukinumab 300 mg s.c. administered Q2W or Q4W
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent must be obtained before any assessment is performed. * Chinese male and female participants ≥ 18 years of age. * Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline. * Participants with moderate to severe HS at baseline defined as: * A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND * Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
Exclusion criteria
* Total fistulae count ≥ 20 at baseline. * Any other active skin disease or condition that may interfere with assessment of HS at baseline. * Active inflammatory bowel disease. * Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious including tuberculosis and hepatitis, or gastrointestinal conditions), which in the opinion of the investigator, significantly immunocompromise the participant and/or place the participant at unacceptable risk for receiving an immunomodulatory therapy. * Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any interventional trial * Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A, IL-17 A/F or the IL-17 receptor. * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving HiSCR50 at Week 16 | Week 16 | HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in AN Count at Week 16 | Week 16 | Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count. |
| Percentage of participants experiencing an HS Flare through Week 16 | Up to Week 16 | Flare is defined as at least a 25% increase in AN count from baseline with a minimum absolute increase of 2 lesions. |
| Percentage of participants achieving NRS30 Skin Pain Response at Week 16 | Week 16 | Among participants with baseline NRS ≥3, NRS30 is defined as ≥30% reduction and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst level). |
| Percentage of participants achieving HiSCR50 through Week 52 | Up to Week 52 | Proportion of participants achieving HiSCR50 (≥50% reduction in AN count with no worsening of abscesses or draining fistulae) with secukinumab 300 mg Q2W or Q4W. |
| Percentage of participants experiencing HS Flares through Week 52 | Up to Week 52 | Flare defined as ≥25% increase from baseline in AN count with a minimum increase of 2 lesions. |
| Percentage of participants achieving NRS30 Skin Pain Response through Week 52 | Up to Week 52 | Proportion of participants achieving NRS30 (≥30% and ≥2-unit reduction in skin pain intensity). |
| Number of participants with Adverse Events through Week 52 | Up to Week 52 | Number of participants with safety and tolerability assessments |
| Change from baseline in AN Count through Week 52 | Up to Week 52 | Absolute and percentage change in AN count relative to baseline. |
Countries
China
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed