Efgartigimod for Low Platelet Count
(ADVANCE SC+ Trial)

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new injection treatment for adults whose immune systems destroy their own platelets. The treatment aims to calm the immune system to stop it from attacking these important blood cells. Romiplostim promotes platelet production and has been used in the treatment of this condition.

Research Team

Eligibility Criteria

This trial is for adults with primary immune thrombocytopenia who completed a previous 24-week study and can commit to another 52 weeks. They must understand the trial, consent to procedures, attend visits, use contraception if applicable, and not be pregnant or breastfeeding.

Inclusion Criteria

Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits)

Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits)

Agree to use contraceptives consistent with local regulations and have a negative urine pregnancy test at baseline before receiving IMP (applicable to female participants of childbearing potential)

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Exclusion Criteria

Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

I am not taking any restricted medications like anti-CD20 therapy or live vaccines.

Use of any other investigational drug or participation in any other investigational trial

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Treatment Details

Interventions

efgartigimod PH20 SC (Monoclonal Antibodies)

Trial OverviewThe safety and effectiveness of efgartigimod PH20 SC (a subcutaneous injection) are being tested in patients with low platelet counts due to primary immune thrombocytopenia over an additional year following a prior study.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention

Patients receiving efgartigimod PH20 SC treatment