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Clinical Trial
. 2023 Sep 15;189(4):381-391.
doi: 10.1093/bjd/ljad186.

Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment

Sascha Gerdes  1 , Petra Staubach  2 , Thomas Dirschka  3 , Dieter Wetzel  4 , Oliver Weirich  5 , Johannes Niesmann  6 , Rodrigo da Mota  7 , Alex Rothhaar  8 , Michael Ardabili  9 , Gerda Vlasitz  10 , Joachim Feldwisch  10 , Lisa Osterling Koskinen  10 , Sven Ohlman  10 , Paul M Peloso  11 , Nikolai C Brun  10 , Fredrik Y Frejd  10   12
Affiliations
Clinical Trial

Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment

Sascha Gerdes et al. Br J Dermatol. .

Abstract

Background: Monoclonal antibodies to interleukin (IL)-17 have shown strong efficacy in patients with psoriasis. Izokibep is a unique IL-17A inhibitor with a small molecular size and favourable distribution to sites of inflammation.

Objectives: To evaluate the dose response, efficacy and safety of izokibep in patients with plaque psoriasis.

Methods: In this double-blind, randomized, phase II dose-finding study (AFFIRM-35) in adults with moderate-to-severe plaque psoriasis and inadequate response to two or more standard therapies, patients were randomized (1:1:1:1:1) to placebo or izokibep 2, 20, 80 or 160 mg every 2 weeks for 12 weeks. During the remainder of the 52-week core study, patients given placebo were switched to izokibep 80 mg, and dosing intervals were adapted based on Psoriasis Area and Severity Index (PASI) scores for all patients. The core study was followed by two optional consecutive 1-year extension periods for a total duration of 3 years. The primary endpoint was a 90% reduction in PASI score (PASI 90) at week 12. Additional efficacy outcomes and adverse event (AE) rates were evaluated.

Results: In total, 109 patients were randomized [safety set, n = 108 (one exclusion criteria failure); full analysis set, n = 106]. At week 12, PASI 90 response rates were 0%, 5%, 19%, 71% and 59% for the placebo, 2-, 20-, 80- and 160-mg izokibep groups, respectively. Rapid dose-dependent improvements were also observed across other efficacy outcomes. During the placebo-controlled period, AEs in the izokibep groups were similar to placebo except for mild injection site reactions. AEs were generally mild to moderate and the drug was well tolerated. Izokibep maintained efficacy at the higher dosage groups for up to 3 years, with no new safety signals.

Conclusions: Data from this phase II study indicate that izokibep is well tolerated and efficacious in the treatment of plaque psoriasis. Higher doses or more frequent dosing could be explored to further enhance response rates.

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Conflict of interest statement

Conflicts of interest: S.G. has received grants, contracts, honoraria, support for meetings/travel and/or participated in advisory or data safety monitoring boards for AbbVie, ACELYRIN, Affibody, Akari Therapeutics, Almirall-Hermal, Amgen, argenx, Aristea Therapeutics, Biogen Idec, Bioskin, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Galderma, Hexal, Incyte, Janssen-Cilag, Johnson & Johnson, Klinge Pharma, Kymab, LEO Pharma, Medac, MSD, Neubourg Skin Care, Novartis, Pfizer, Pierre Fabre, Principia Biopharma, Regeneron Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi-Aventis, Trevi Therapeutics and UCB Pharma; and has received equipment, materials, drugs, medical writing or other services from AbbVie, Almirall-Hermal, Amgen, Celgene, Eli Lilly, Janssen-Cilag, LEO Pharma, Medac, Novartis, Pfizer, Sanofi-Aventis and UCB Pharma. P.S. has received grants, contracts, honoraria, support for meetings/travel and/or has participated in advisory or data safety monitoring boards for AbbVie, Allergika, Almirall-Hermal, Amgen, Beiersdorf, Biocryst, BMS, Boehringer Ingelheim, Celgene, CSL-Behring, Eli Lilly, Galderma, Hexal, Janssen, Klinge, Klosterfrau, LEO Pharma, LETI Pharma, L’Oréal, Novartis, Octapharma, Pfizer, Pflüger, Pharming, Regeneron, Shire, Takeda, Regeneron, Sanofi-Genzyme und UCB Pharma. D.W. has received consulting fees from Affibody and ACELYRIN. M.A. has received grants, contracts and/or consulting fees from Arbeitsgemeinschaft Dermatologische Prävention (ADP) Education of Referees for certificate “Hautkrebs-Screening” issued by Zentralinstitut für Kassenärztliche Versorgung, Lumenis and various companies involved in laser treatments in dermatology. G.V. has received consulting fees from Affibody. J.F. is an employee of Affibody, owns stock in Affibody and is a patent holder of five patents involving interleukin-17A-binding and albumin-binding polypeptides. L.O.K., S.O. and N.C.B. are employees of Affibody and have stock options for Affibody. P.P. is an employee of ACELYRIN and has stock options for ACELYRIN. F.Y.F. is an employee of Affibody, owns stock in Affibody and has stock options for Affibody. T.D., O.W., J.N., R.d.M, and A.R. declare no conflicts of interest.

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