A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Biological: Placebo
- Registration Number
- NCT04856930
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
- Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
- HS lesions present in at least 2 distinct anatomical areas.
- Total Abscess and inflammatory nodule (AN) count ≥ 5.
- Draining fistulas less than or equal to (≤) 20.
- Stable HS for at least 6 weeks prior to Day 1 visit.
1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imsidolimab 400/200 milligrams (mg) Imsidolimab 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks Imsidolimab 200/100 mg Imsidolimab 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks Placebo Placebo Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16). Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197). After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in AN Count at Week 16: Placebo-Controlled Period Baseline, Week 16 The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period Baseline, Week 16 The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period Week 16 The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows:
A responder HiSCR50 was defined as a participant with
1. at least a 50% decrease in AN count from Baseline, and
2. no increase in abscess count relative to Baseline, and
3. no increase in draining fistula count relative to BaselineChange From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period Baseline, Week 16 Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period Baseline, Week 16 Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period Baseline, Week 16 Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period Baseline, Week 16 Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period From first dose (placebo-controlled period) up to Week 16 An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Number of Participants With TEAEs: Extension and Follow-up Period From first dose (extension period) up to Week 40 An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Trial Locations
- Locations (34)
Site 10-108
🇺🇸Birmingham, Alabama, United States
Site 10-104
🇺🇸Fountain Valley, California, United States
Site 10-119
🇺🇸Northridge, California, United States
Site 10-102
🇺🇸Sacramento, California, United States
Site 10-109
🇺🇸Coral Gables, Florida, United States
Site 10-107
🇺🇸Largo, Florida, United States
Site 10-111
🇺🇸Tampa, Florida, United States
Site 10-110
🇺🇸Sandy Springs, Georgia, United States
Site 10-101
🇺🇸Fort Gratiot, Michigan, United States
Site 10-103
🇺🇸Portsmouth, New Hampshire, United States
Scroll for more (24 remaining)Site 10-108🇺🇸Birmingham, Alabama, United States