CT-P55 (secukinumab biosimilar) / Celltrion - LARVOL DELTA

A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis (clinicaltrials.gov) - P3 | N=153 | Active, not recruiting | Sponsor: Celltrion | Not yet recruiting ➔ Active, not recruiting | N=375 ➔ 153

Enrollment change • Enrollment closed • Dermatology • Immunology • Psoriasis

Pharmacokinetics and safety of candidate biosimilar CTP55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, phase I study. (PubMed, Expert Opin Investig Drugs) - P1 | "Generalizability may be limited beyond Asian males. The study is registered at Clinicaltrials.gov (NCT07054970)."

Clinical • First-in-human • Journal • P1 data • PK/PD data

Celltrion said on the 11th that it won approval from the European Medicines Agency for a change to the clinical trial plan for CT-P55, a psoriasis treatment (Chosun Biz) - "Celltrion is conducting a global phase 3 trial of CT-P55 in patients with plaque psoriasis. The process is aimed at proving the efficacy, safety, and equivalence of Cosentyx and CT-P55. The company plans to reduce the number of patients participating in phase 3 from 375 to 153. It said this could reduce clinical expense and time and lower development costs."

Clinical protocol • Psoriasis

Pharmacokinetics, Safety and Immunogenicity comparision of Secukinumab Biosimilar (CT-P55) with Reference Secukinumab in Healthy male Subjects (EADV 2025) - "This study demonstrated PK equivalence of CT-P55 to both EU- and US-sourced reference secukinumab in healthy subjects. Safety profiles, including immunogenicity, were comparable across the three treatment arms, with no new safety signals identified for CT-P55."

Clinical • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Celltrion highlights the strength of its expanding dermatology portfolio with positive clinical results for CT-P55, a biosimilar candidate referencing secukinumab (Businesswire) - "...Celltrion presented an abstract for its proposed secukinumab biosimilar candidate, CT-P55 which demonstrated comparable efficacy and safety profiles to the reference secukinumab in healthy subjects."

P1 data • Immunology

Celltrion showcases novel pipeline competitiveness, featuring OMLYCLO, ahead of European launch at EADV [Google translation] (BioNews) - "On September 18, the second day of the congress, Celltrion will host a symposium...During this session, key opinion leaders (KOLs) from across Europe will present clinical data from the 40-week global Phase 3 clinical trial of OMLYCLO, including post-treatment follow-up data, while also addressing the broader competitiveness of biosimilars....Celltrion will also unveil, for the first time, results from the global Phase 1 clinical trial of CT-P55..."

Clinical data • Chronic Spontaneous Urticaria • Immunology

To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects (clinicaltrials.gov) - P1 | N=172 | Completed | Sponsor: Celltrion

New P1 trial

Celltrion launches phase 3 trial for psoriasis biosimilar CT-P55 in Europe (Chosun Biz) - "Celltrion announced on the 18th that it has received approval from the European Medicines Agency (EMA) for the clinical phase 3 trial plan (IND) for the psoriasis treatment Cosentyx (COSENTYX, active ingredient secukinumab) biosimilar...and the substance patent will expire in the U.S. in January 2029 and in Europe in July 2030. With this approval, Celltrion will begin a global phase 3 clinical trial for CT-P55, a biosimilar of Cosentyx, involving 375 patients with plaque psoriasis."

New P3 trial • Patent • Immunology • Psoriasis

Celltrion Expands Autoimmune Disease Portfolio…'CT-P55' in Phase 3 in Europe [Google translation] (Health in News) - "Celltrion announced on the 14th that it has submitted an investigational new drug (IND) for the global phase 3 clinical trial of Cosentyx (ingredient: secukinumab) biosimilar 'CT-P55' to the Clinical Trials Information System (CTIS) managed by the European Medicines Agency. This phase 3 clinical trial will be conducted on 375 patients with plaque psoriasis, and will compare the efficacy and safety of the original drug Cosentyx and 'CT-P55' to demonstrate equivalence. Cosentyx is an interleukin (IL)-17A inhibitor widely used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis."

New P3 trial • Immunology • Psoriasis

A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis (clinicaltrials.gov) - P3 | N=375 | Not yet recruiting | Sponsor: Celltrion

New P3 trial • Dermatology • Immunology • Psoriasis

Celltrion, Cosentyx Similar 'CT-P55' US Phase 3 IND Application [Google translation] (Hankyung) - "Celltrion announced that it has submitted an investigational new drug (IND) application for the global phase 3 clinical trial of Cosentyx (ingredient name: secukinumab) biosimilar 'CT-P55' to the U.S. Food and Drug Administration (FDA). This global clinical trial will involve a total of 375 patients with plaque psoriasis, and is a comparative study to prove the equivalence of efficacy and safety between the original drug and CT-P55."

IND • New P3 trial • Immunology • Psoriasis

Celltrion's Cosentyx biosimilar gets nod for phase 1 study in Japan (The Korea Herald) - "South Korean biosimilar giant Celltrion said Monday it has gained approval for a phase one clinical trial of CT-P55 from a Japanese regulatory authority....Upon approval from the Tokyo-based Pharmaceuticals and Medical Devices Agency, Celltrion will conduct a phase one clinical study with a total of 171 Japanese adults to compare the pharmaceutical equivalence of CT-P55 to Cosentix."

New P1 trial • Immunology • Psoriasis