XEMBIFY vs Gamunex-C for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

(XPERT Trial)

Recruiting at 1 trial location

Overseen By Olga Titova

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Grifols Therapeutics LLC

Must be taking: IGIV

Must not be taking: Alemtuzumab, Rituximab, Cyclophosphamide, others

Disqualifiers: Polyneuropathy, Malignancy, Cardiac insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 23

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.

Participants with CIDP will first have up to 28 days of screening to make sure they can join the study. Those who qualify will then start a 19-week treatment period with Gamunex-C. During this period, they will receive Gamunex-C through a vein once every 3 weeks, for a total of 7 doses. Approximately, one week after their last Gamunex-C dose, they will begin a 16-week treatment period with XEMBIFY under the skin, once a week for a total of 16 doses. Blood samples will be collected during both treatment periods to measure IgG level in the blood.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP.

My weight is 90 kg or less and I need 0.3-1.0 g/kg of IGIV every three weeks.

My CIDP treatment has not changed and I have been stable for at least 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment with Gamunex-C

Participants receive Gamunex-C intravenously every 3 weeks for a total of 7 doses

19 weeks

7 visits (in-person)

Treatment with XEMBIFY

Participants receive XEMBIFY subcutaneously once a week for a total of 16 doses

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gamunex-C
• XEMBIFY

How Is the Trial Designed?

Group I: Xembify (IGSC 20%) Experimental Treatment 1 Intervention

Approximately 7 to 10 days after the last Gamunex-C dose, participants will enter a 16-week SC Phase, where they will receive XEMBIFY 0.456 g/kg once weekly for a total of 16 doses, up to a maximum dose of 41 g.

Group II: Gamunex-C (IGIV-C 10%) Experimental Treatment 1 Intervention

During the IV Phase, participants will receive Gamunex-C 1 g/kg, up to a maximum dose of 90 g, every 3 weeks for a total of seven doses. Gamunex-C may be administered over 1 day or divided into 2 consecutive daily doses of 0.5 g/kg each, except for dose #6, which will be administered as a single 1g/kg dose.

Who Is Running the Clinical Trial?

Grifols Therapeutics LLC

Lead Sponsor

Trials

59

Recruited

6,000+