WHO ICTRP trial

OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)

EUCTR2018-000075-33-CZ · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2018-000075-33-CZ
Public title OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)
Scientific title A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN
Primary sponsor Omeros Corporation
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Singapore;Hungary;United States;Philippines;United Kingdom;Malaysia;Thailand;Spain;Greece;Canada;Czech Republic;Sweden;Austria;Belgium;Taiwan;Korea, Republic…
Conditions IgA nephropathy (IgAN) MedDRA version: 20.1 Level: PT Classification code 10029151 Term: Nephropathy System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Interventions Product Code: OMS721 Pharmaceutical Form: Solution for infusion INN or Proposed INN: OMS721 Other descriptive name: OMS721 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 370- Pharmaceutical form of the…
Registration date Jun 4, 2018
Target size 450
Secondary IDs OMS721-IGA-001;2018-000075-33-HU
Registry page clinicaltrialsregister.eu

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