Evidence map›Paper›PMID 33617042›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2021

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, P Jarvis, I Rozenberg, F Kolbinger, F Di Padova, C Calonder, P Espie, J M Rondeau, R Cebe, T Huber and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  5. Review
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  12. Article
  13. New and Emerging Targeted Therapies for Hidradenitis Suppurativa.International journal of molecular sciences · 2022
    Review
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  16. New perspectives on the treatment of hidradenitis suppurativa.Therapeutic advances in chronic disease · 2021
    Review
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

M KaulNovartis Institute for Biomedical Research, Basel, Switzerland.
P JarvisNovartis Institute for Biomedical Research, Basel, Switzerland.
I RozenbergNovartis Institute for Biomedical Research, Basel, Switzerland.
F KolbingerNovartis Institute for Biomedical Research, Basel, Switzerland.
F Di PadovaNovartis Institute for Biomedical Research, Basel, Switzerland.
C CalonderNovartis Institute for Biomedical Research, Basel, Switzerland.
P EspieNovartis Institute for Biomedical Research, Basel, Switzerland.
J M RondeauNovartis Institute for Biomedical Research, Basel, Switzerland.
R CebeNovartis Institute for Biomedical Research, Basel, Switzerland.
T HuberNovartis Institute for Biomedical Research, Basel, Switzerland.
R MussmannNovartis Institute for Biomedical Research, Basel, Switzerland.
M AassiNovartis Pharma AG, Basel, Switzerland.
T S SlighProvidence Clinical Research, North Hollywood, California, USA.

Funding

Novartis Pharma AG
6 · The paper itself

Abstract

BACKGROUND AND

objectiveAnti-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.

methodsThis 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.

results96 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.

conclusionsCJM112 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.

Indexed as

Interleukin-17PsoriasisAntibodies, MonoclonalDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalInterleukin-17

Identifiers

PMID33617042
PMCPMC8246720

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.