A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Condition(s) studied

Investigational drug(s) / intervention(s)

efgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC

Study summary

The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP). Participants who completed the 24-week trial period of the ARGX- 113-2004 trial are given the opportunity to enter into this open-label extension trial and receive efgartigimod PH20 SC.

Participants will be offered the opportunity to continue in this trial if they have completed the first 52-week treatment period unless efgartigimod becomes commercially available for patients with primary ITP or becomes available through another program for patients with primary ITP, whichever comes first. A maximum of three additional 52-week treatment periods will be offered to the participant to continue this trial.

The total trial duration per participant is up to 4 years (52-week treatment period, extendable with three additional 52-week treatment periods) + 8 weeks follow-up period.

Eligibility

Primary outcome measure(s)

• Incidence of AEs, AESIs, SAEs — Up to 216 weeks
  AE : adverse event ; SAE : Serious adverse event ; AESI : adverse event of special interest.
• Vital sign measurement: blood pressure in the overall population — Up to 216 weeks
• ECG: PR, QT and QRS interval in the overall population — Up to 216 weeks
• Laboratory safety evaluations: CRP analysis in the overall population — Up to 216 weeks

Trial sites (83)

+ 43 more sites — see the full list on the official registry below.

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