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

Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Timeline

Start

2021-05-15

Primary completion

2022-02-01

Completion

2022-03-29

Outcome

Missed primary endpoint

registry analysis (superiority test); Imsidolimab 400/200 mg vs Placebo; p = 0.3757; LS Mean Difference 2.9 (90% CI -2.47 to 8.19); LRMM NCT04856917 ↗

registry analysis (superiority test); Imsidolimab 200/100 mg vs Placebo; p = 0.6183; LS Mean Difference 1.6 (90% CI -3.73 to 6.95); LRMM NCT04856917 ↗

release “clinical trial of imsidolimab for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy” anaptysbio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imsidolimab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Imsidolimab	Monoclonal antibody	200 mg	Subcutaneous

Indications