Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 May;35(5):1143-1151.
doi: 10.1111/jdv.17071. Epub 2021 Jan 5.

First-in-human study demonstrating the safety and clinical efficacy of novel anti-IL-17A monoclonal antibody CJM112 in moderate to severe plaque psoriasis

M Kaul  1 , P Jarvis  1 , I Rozenberg  1 , F Kolbinger  1 , F Di Padova  1 , C Calonder  1 , P Espie  1   2 , J M Rondeau  1 , R Cebe  1 , T Huber  1   3 , R Mussmann  1 , M Aassi  4 , T S Sligh  5
Affiliations
Randomized Controlled Trial

First-in-human study demonstrating the safety and clinical efficacy of novel anti-IL-17A monoclonal antibody CJM112 in moderate to severe plaque psoriasis

M Kaul et al. J Eur Acad Dermatol Venereol. 2021 May.

Abstract

Background and objective: Anti-IL-17A IgG/κ monoclonal antibody CJM112 binds both IL-17A and IL-17AF. The purpose of this First-in-Human study was to assess CJM112 effects on safety and efficacy in patients with moderate to severe plaque psoriasis.

Methods: This study had two parts: single ascending doses of 5-450 mg subcutaneous (s.c.) CJM112 (SAD) and multi-dose parallel groups of CJM112 15 mg, 50 mg and 150 mg s.c. low frequency or high frequency (MD). SAD/MD were double-blind, randomized and placebo-controlled; MD also included a secukinumab 150 mg s.c. arm as an active comparator. Patients 18-65 years with moderate to severe psoriasis were included in this study. The efficacy outcome was the change in Psoriasis Area Severity Index (PASI) from baseline to Week 4 in the SAD part of the study, and from baseline to Week 12 in the MD part.

Results: 96 patients were enrolled in this study (SAD, n = 42; MD, n = 54). In SAD, CJM112 doses from 15 mg and above demonstrated higher PASI responses compared with placebo at Week 12. CJM112 450 mg did not add further efficacy, but efficacy duration was prolonged compared with CJM112 150 mg. CJM112 MD resulted in a dose-dependent decrease in PASI over time to Week 12. CJM112 150 mg high frequency did not exceed the effect of CJM112 150 mg low frequency and had similar efficacy to secukinumab 150 mg. The safety profile of CJM112 was as expected for an antibody targeting IL-17A/IL-17AF.

Conclusions: CJM112 had clinical efficacy in moderate to severe psoriasis and was generally safe and well tolerated in the doses tested. Additional neutralization of IL-17AF did not translate to increased clinical efficacy compared with secukinumab.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study Design. Schematic describing study design for study Part I single ascending dosing (SAD) and Part II multiple dosing (MD). Results from the first interim analysis in SAD were used to determine both which cohort to expand and the dosing strategy for MD.
Figure 2
Figure 2
CJM112 single ascending dose (SAD) reduction in PASI over time. Line graph demonstrating mean percentage change of PASI from baseline to Week 12 following a single dose of CJM112 compared with placebo. PASI, Psoriasis Area Severity Index.
Figure 3
Figure 3
CJM112 multiple dosing (MD) reduction in PASI over time. Line graph demonstrating mean percentage change of PASI from baseline to Week 12 following multiple dosing of CJM112 compared with placebo and secukinumab. PASI, Psoriasis Area Severity Index.
See this image and copyright information in PMC

References

    1. Dalgard FJ, Gieler U, Tomas‐Aragones L, Lien L, Poot F, Jemec GBE et al. The psychological burden of skin diseases: a cross‐sectional multicenter study among dermatological out‐patients in 13 European countries. J Invest Dermatol 2015; 135: 984–991. - PMC - PubMed
    1. Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol 1998; 139: 846–850. - PubMed
    1. Christophers E, Barker JN, Griffiths CE, Dauden E, Milligan G, Molta C et al. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J Eur Acad Dermatol Venereol 2010; 24: 548–554. - PubMed
    1. Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harb Perspect Med 2014; 4: a015354. - PMC - PubMed
    1. Gisondi P, Fostini AC, Fossa I, Girolomoni G, Targher G. Psoriasis and the metabolic syndrome. Clin Dermatol 2018; 36: 21–28. - PubMed

Publication types

Grants and funding