Hidradenitis
Conditions
Brief summary
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.
Interventions
DRUGDuvakitug
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
DRUGPlacebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Sponsors
Sanofi
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline Visit * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III. * Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit. * Participants must have had an inadequate response to a course of a systemic antibiotics for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics, or has a contraindication to systemic antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. * Participants must have a prior HS treatment history consistent with the following: * For the biologic and immunosuppressive small molecule-naïve subgroup, participants must have no history of treatment with any approved or investigational biologic therapy or small molecule immunosuppressive therapy with potential efficacy for HS. * For the biologic and immunosuppressive small molecule-experienced subgroup, participants must have a history of treatment with at least 1 biologic or immunosuppressive small molecule therapy with potential efficacy for HS.
Exclusion criteria
* Participants are excluded from the study if any of the following criteria apply: * Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * History of systemic hypersensitivity or anaphylaxis to any biologic therapy * History of recurrent or recent serious infection * Known history of or suspected significant current immunosuppression * History of solid organ transplant or stem cell transplant. * History of splenectomy * History of malignancy or suspicion of malignancy within 5 years prior to the Screening Visit (except for in situ cervical carcinoma that has been treated by surgery and completely cured, or basal cell carcinoma or squamous cell carcinoma that has been excised and completely cured) * History within the 2 years prior to Baseline Visit of prescription drug or substance abuse, including alcohol, considered significant by the Investigator. * Any medical or psychiatric condition which, in the opinion of the Investigator could be considered uncontrolled, unstable, or likely to progress in a clinically relevant manner and may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments. * Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable, or may interfere with study assessments. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | At Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | At Week 16 | 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) |
| Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4) | From baseline to Week 16 | 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. |
| Percentage of participants achieving Achievement of Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) | At Week 16 | 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. |
| Percent change from baseline to Week 16 in draining tunnel count | 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 | From Baseline to week 16 | 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). |
| Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score | From Baseline to Week 16 | 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. |
| Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score | From Baseline to Week 16 | 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. |
| 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 | Up to End of Study (approximately 145 weeks) | — |
| Serum concentrations of duvakitug throughout the study | Up to End of Study (approximately 145 weeks) | — |
| Incidence of treatment-emergent anti-drug antibodies (ADA) against duvakitug over time | Up to End of Study (approximately 145 weeks) | — |
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed