WHO ICTRP trial
A study to investigate the efficacy and safety of efgartigimod PH20 SC in adult…
EUCTR2021-001277-23-IT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-001277-23-IT |
|---|---|
| Public title | A study to investigate the efficacy and safety of efgartigimod PH20 SC in adult participants with active idiopathic inflammatory myopathy |
| Scientific title | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With… |
| Primary sponsor | ARGENX BV |
| 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): yes Therapeutic use (Phase IV): no |
| Countries | United States;Czechia;Thailand;Portugal;Greece;Austria;Sweden;Netherlands;Ireland;Korea, Republic of;Poland;Slovakia;France;Lithuania;Bulgaria;Serbia;Argentina;Hungary;Japan;United… |
| Conditions | Active Idiopathic Inflammatory Myopathy (IIM) MedDRA version: 24.1 Level: PT Classification code 10085970 Term: Idiopathic inflammatory myopathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic… |
| Interventions | Product Name: efgartigimod PH20 SC Product Code: [ARGX-113] Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: efgartigimod alfa CAS Number: 1821402-21-4 Current Sponsor code: ARGX-113 Concentration unit: mg/ml… |
| Registration date | Oct 20, 2022 |
| Target size | 240 |
| Secondary IDs | ARGX-113-2007;2021-001277-23-DK |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: