A multi-centre, open-label, phase 1 study, Part A single ascending dose and Part B multiple dose, to evaluate the safety, tolerability and pharmacokinetics, and to explore early signs of effectiveness of induction of antigen-specific immune tolerance with TPM203 in pemphigus vulgaris patients

Topas Therapeutics GmbH0 个研究点目标入组 24 人开始时间: 2019年6月12日最近更新: 2022年3月28日

适应症

试验速览

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•1. Written informed consent to take part in the study
•2.Patient (male or female) age =18 years and =70 years
•3.Body weight of =50 kg and a body mass index =18.5 and =32 kg/m2
•4.Diagnosis with PV (documented) and at screening complete clinical remission or low to moderate clinical disease activity (i.e. ABSIS =17 and PDAI =15)
•5.Presence of anti-Dsg3 IgG (immunoglobulin G) antibodies and peripheral blood CD4+ T cells specific for at least one of the Dsg3 peptides employed in TPM203 in blood samples at screening or presence of human leucocyte antigen (HLA)-DRB1*04:02 and/or HLA-DQB1*05:03.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1.Immunosuppressive or immunomodulatory treatment during the study other than prednisolone =10 mg/d for patients with body weight <70 kg or =12.5 mg/d for patients with body weight = 70 kg (or equipotent doses of other steroids)
•2.Conditions including previous or concomitant medication that might present a risk to the patient and/or impede the attainment of the study's objectives.

发起方