Clinical trial

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris

NCT04856917

Name

ANB019-209

Description

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Trial arms

Trial start

2021-05-15

Estimated PCD

2022-02-01

Trial end

2022-03-29

Status

Completed

Phase

Early phase I

Treatment

Imsidolimab

Humanized Monoclonal Antibody

Arms:

Imsidolimab 200/100 mg, Imsidolimab 400/200 mg

Other names:

ANB019

Placebo

Arms:

Placebo

Size

123

Primary endpoint

Change From Baseline in Facial Inflammatory Lesion Counts at Week 12

Baseline, Week 12

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 123, 'type': 'ACTUAL'}}

Updated at

2023-06-15

1 organization

2 products

1 indication

Organization

Product

Indication

Product