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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Biological: Placebo; Drug: Imsidolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856917

ANB019-209

Details and patient eligibility

About

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Full description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.

Enrollment: 123 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of moderate to severe facial AV
• Facial IGA) score of 3 (moderate) or 4 (severe)
• At least 20 and no more than 100 inflammatory lesions on the face
• No more than 100 non-inflammatory lesions on the face.
• No more than 5 nodules (≥5 millimeter [mm]) on the face

Key Exclusion Criteria:

• A participant with acne fulminans or conglobate or secondary acne will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 3 patient groups, including a placebo group

Imsidolimab 400/200 mg

Experimental group

Description:

Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.

Treatment:

Drug: Imsidolimab

Imsidolimab 200/100 mg

Experimental group

Description:

Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.

Treatment:

Drug: Imsidolimab

Placebo

Placebo Comparator group

Description:

Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.

Treatment:

Biological: Placebo