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 Active Idiopathic Inflammatory Myopathy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512785-33-00

Acronym

ARGX-113-2007

Enrollment

186

Registered

2024-08-14

Start date

2023-03-01

Completion date

Unknown

Last updated

2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Idiopathic Inflammatory Myopathy (IIM)

Brief summary

Total improvement score (TIS)

Detailed description

Time to reach TIS ≥20 (first "minimal clinical improvement"), Percentage of participants with TIS ≥20, Time to reach TIS ≥40 (first "moderate clinical improvement"), Percentage of participants with TIS ≥40, Change in manual muscle testing-8 (MMT8) score, Change in Patient Global Assessment of Disease Activity (PGA), Change in Physician Global Assessment of Disease Activity (MDGA), Proportion of participants achieving target oral prednisone dosage of ≤ 5 mg/day (or equivalent)

Interventions

DRUGPlacebo to ARGX-113 solution for injection

DRUGARGX-113

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Total improvement score (TIS)	—

Secondary

Measure	Time frame
Time to reach TIS ≥20 (first "minimal clinical improvement"), Percentage of participants with TIS ≥20, Time to reach TIS ≥40 (first "moderate clinical improvement"), Percentage of participants with TIS ≥40, Change in manual muscle testing-8 (MMT8) score, Change in Patient Global Assessment of Disease Activity (PGA), Change in Physician Global Assessment of Disease Activity (MDGA), Proportion of participants achieving target oral prednisone dosage of ≤ 5 mg/day (or equivalent)	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026