Anti-IL-17A blockade did not significantly reduce inflammatory lesions in a placebo-controlled pilot study in adult patients with moderate to severe acne

  • J Dermatolog Treat. 2023 Dec;34(1):2138691. doi: 10.1080/09546634.2022.2138691.
Diane M Thiboutot  1 Noah Craft  2  3 Robert Rissmann  4  5 Ewa Gatlik  6 Malika Souquières  6  7 Julie Jones  8 Christian Loesche  6
Affiliations
  • 1. Department of Dermatology, Pennsylvania State University College of Medicine, Hershey, PA, USA.
  • 2. Department of Dermatology, Good Dermatology, Torrance, CA, USA.
  • 3. Department of Dermatology, People Science, Venice, CA, USA.
  • 4. Department of Dermatology, Centre for Human Drug Research, Leiden, The Netherlands.
  • 5. Department of Biotherapeutics, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands.
  • 6. Novartis Institute for Biomedical Research, Basel, Switzerland.
  • 7. Priothera SAS, Saint-Louis, France.
  • 8. Biostatistical Sciences and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland.
Abstract

Background: CJM112 is a potent anti-IL-17A monoclonal antibody, whose clinical efficacy in psoriasis was recently documented. This study aimed to assess the effect of IL-17A blockade, using CJM112, in patients with moderate to severe acne.

Methods: A randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study was conducted on patients with moderate to severe acne. Patients received CJM112 300 mg, 75 mg, or placebo subcutaneously during Treatment Period 1 (0-12 weeks). Patients receiving placebo were re-randomized to receive CJM112 300 mg or 75 mg during Treatment Period 2 (12-24 weeks). The primary endpoint was the number of inflammatory facial lesions at Week 12.

Results: As the futility criterion was met during the interim analysis, only 52/75 (69.3%) patients were recruited. In total, 48/52 (92.3%) and 26/41 (63.4%) completed Treatment Periods 1 and 2, respectively. All groups exhibited a reduction in facial inflammatory lesions, with no difference observed between CJM112 and placebo (CJM112 300 mg 27.6 ± 20.7; CJM112 75 mg 30.4 ± 34.8; placebo 23.6 ± 13.6; primary endpoint). Additionally, no differences were observed between groups in Other secondary and exploratory endpoints at Week 12.

Conclusions: Anti-IL-17A therapy was not significantly different compared to the placebo in reducing inflammatory lesions in patients with moderate to severe acne.

Keywords
Acne vulgaris; CJM112; anti-IL-17A; inflammatory lesions; scarring.
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