Efgartigimod SC for CIDP

(ADHERE+ Trial)

Recruiting at241 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: argenx

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Research Team

Eligibility Criteria

This trial is for adults with CIDP, an autoimmune disorder affecting nerves. Participants must have been part of a prior efgartigimod study or treatment and deteriorated during that time. They should understand the trial's demands, consent in writing, follow procedures, and use contraception if applicable. Pregnant women or those with serious diseases or recent major surgeries are excluded.

Inclusion Criteria

Your condition got worse during the previous stage of the trial and you can be treated with efgartigimod PH20 SC.

I am a woman who can have children, not pregnant, and using birth control.

I have been treated with efgartigimod PH20 SC or participated in its trials.

Exclusion Criteria

Pregnant, lactating, or intending to become pregnant during the trial

Participation in previous trials or treatment cycles outside specified timeframes

I do not have any serious health issues or recent major surgeries that could affect the trial.

Treatment Details

Interventions

• Efgartigimod PH20 SC (Monoclonal Antibodies)

Trial Overview The study tests long-term safety and effectiveness of Efgartigimod PH20 SC (a drug given under the skin) in adults with CIDP. It includes patients stabilized on this medication from a previous phase II trial and explores less frequent dosing options within a sub-study.

Participant Groups

Group I: efgartigimod PH20 SC Experimental Treatment 1 Intervention

Patients treated with efgartigimod PH20 SC

Efgartigimod PH20 SC is already approved in Japan, China for the following indications:

Approved in Japan as VYVDURA for:

• Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive

Approved in China as Efgartigimod alfa injection (subcutaneous injection) for:

• Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University