A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Conditions

• CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gamunex-C — BIOLOGICAL
  Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%)
• Xembify — BIOLOGICAL
  Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)

Study Details

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.

Key Dates

Start date

Apr 2, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Gamunex-C (IGIV-C 10%)
  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.
• Experimental: Xembify (IGSC 20%)
  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.

Primary Outcome Measure

AUC in the IV Phase: Steady-state area under the concentration-time curve (AUC) of total IgG over a 3-week intravenous dosing interval (τ) (i.e., AUC(0-21days) in participants with CIDP [ Time Frame: Week 1 to 19 of IV Phase ]

Central Contacts

• Sarah Duggan
  +353 87 429 2411
  [email protected]
• Olga Titova
  [email protected]

Locations (5)

Find similar trials in Rancho Mirage, CA

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