WHO ICTRP trial

A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe…

EUCTR2021-000725-28-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2021-000725-28-ES
Public title A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic Dermatitis
Scientific title A Phase IIb, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis (Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis. The…
Primary sponsor Kymab Limited
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Czechia;Hungary;Taiwan;Canada;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom;Japan
Conditions Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Interventions Product Name: KY1005 Product Code: SAR445229 Pharmaceutical Form: Solution for injection INN or Proposed INN: amlitelimab CAS Number: 2378692-15-8 Current Sponsor code: KY1005 and SAR445229 Other descriptive name: KY1005 is a human…
Registration date Feb 11, 2021
Target size 350
Secondary IDs KY1005-CT05_(DRI17366)
Registry page clinicaltrialsregister.eu

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