This is a parallel, Phase 2b, 3-arm, double-blind, randomized, multicenter, multinational, placebo-controlled, dose-ranging study to evaluate the efficacy and the safety of different doses of duvakitug in adult participants with moderate to severe hidradenitis suppurativa. Study details include: * The study duration will be up to 145 weeks , including a 4-week screening period, a 16-week initial double-blind treatment period, a 24-week active blinded extension period, a 96-week long-term extension period and a 5-week follow-up period. * The treatment duration will be up to 40 weeks for the participants who will stop after the active blinded extension period and up to 136 weeks for the participants who will continue in the long-term extension period. * The number of visits will be up to 23 for the participants who will stop after the active blinded extension period and up to 71 for the participants who will continue in the long-term extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Time frame: At Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count)
Time frame: At Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Time frame: From baseline to Week 16
Percentage of participants achieving Achievement of Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Time frame: At Week 16
Percent change from baseline to Week 16 in draining tunnel count
Time frame: From Baseline to week 16
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS.Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period).
Time frame: From Baseline to week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Time frame: From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
The Hidradenitis Suppurativa Quality of Life (HiSQoL) is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
Time frame: From Baseline to Week 16
Number of participants with Treatment Emergent Adverse Events (TEAEs) Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) leading to treatment discontinuation, and TEAESIs, throughout the study
Time frame: Up to End of Study (approximately 145 weeks)
Serum concentrations of duvakitug throughout the study
Time frame: Up to End of Study (approximately 145 weeks)
Incidence of treatment-emergent anti-drug antibodies (ADA) against duvakitug over time
Time frame: Up to End of Study (approximately 145 weeks)
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