A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Biological: Placebo; Biological: Imsidolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856930

2021-001440-99 (EudraCT Number)

ANB019-208

Details and patient eligibility

About

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
2. HS lesions present in at least 2 distinct anatomical areas.
3. Total Abscess and inflammatory nodule (AN) count ≥ 5.
4. Draining fistulas less than or equal to (≤) 20.
5. Stable HS for at least 6 weeks prior to Day 1 visit.

Exclusion criteria

1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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149 participants in 3 patient groups, including a placebo group

Imsidolimab 400/200 milligrams (mg)

Experimental group

Description:

400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks

Treatment:

Biological: Imsidolimab

Imsidolimab 200/100 mg

Experimental group

Description:

400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks

Treatment:

Biological: Imsidolimab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo