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Not recruiting
Phase 2

Efgartigimod PH20

Sponsor:

argenx

Code:

NCT06503731

Conditions

Antibody-mediated Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod PH20 SC - prefilled syringe

Placebo PH20 SC - prefilled syringe

Study Details

Brief summary:

The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.

After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Conditions

Antibody-mediated Rejection

Study ID

NCT06503731

Start date

Aug 30, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The participant is within the ages of 18 and 80 years old
  • The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
  • The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
  • A participant may be allowed into the study if they receive the following medications:

1. Received mycophenolate mofetil for at least 20 weeks before the study
2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
4. Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study

Exclusion Criteria:

  • Confirmed T-cell or mixed rejection at time of the study
  • Recent change in immunosuppressive therapy agents
  • Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
  • Pregnant or lactating state or intention to become pregnant during the study

The complete list of criteria can be found in the protocol

Study Design

Enrollment

33 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm 1

Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)

experimental: Treatment arm 2

Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48

placebo comparator: Treatment arm 3

Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)

Interventions

Efgartigimod PH20 SC - prefilled syringe

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC - prefilled syringe

Subcutaneous placebo PH20 SC given by prefilled syringe

Primary outcome measure

  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 78 weeks ]
  • Percentage of participants with permanent treatment discontinuation due to adverse events (AEs) [ Time Frame: Up to 48 weeks ]

Central Contacts and Locations

More Information

Sponsor

argenx

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • Active AMR
  • Chronic active AMR
  • Late AMR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by argenx on 2026-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.