Ripertamab for the Treatment of Myasthenia Gravis (RIPERT-MG)

January 19, 2026 updated by: Zhongming Qiu

Safety and Efficacy of Ripertamab in Generalized Myasthenia Gravis

The goal of this clinical trial is to learn if ripertamab works to treat myasthenia gravis. It will also learn about the safety of ripertamab. The main questions it aims to answer are:Will ripertamab improve the symptoms of participants?What medical problems do participants have when using ripertamab?Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.Participants will:A single intravenous infusion of ripertamab.Visit the clinic for checkups and tests during W1, W2, W4, W8, W12. Keep a diary of their symptoms and the number of times they undergo rescue therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

(1) Aged ≥ 18 years and ≤ 75 years at screening.(2) Confirmed diagnosis of generalized myasthenia gravis (gMG).(3) Positive for anti-acetylcholine receptor (anti-AChR), anti-muscle-specific kinase (anti-MuSK), and/or anti-low-density lipoprotein receptor-related protein 4 (anti-LRP4) antibodies.(4) A score of ≥ 6 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale, with the ocular subscore accounting for less than 50% of the total score.(5) Classified as Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Types Ⅱ, Ⅲ, or Ⅳ.(6) Voluntary signing of the informed consent form by the patient and/or their legal representative.

Exclusion Criteria:

(1) Any condition that the investigator deems likely to interfere with the evaluation of the study drug, assessment of patient safety, or interpretation of study results.(2) A history of any uncontrolled active infection or severe infection within 8 weeks prior to screening.(3) Receipt of rituximab or any B-cell depleting agent within 6 months prior to screening; note: Subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal are eligible for enrollment.(4) Administration of tocilizumab, eculizumab, mitoxantrone, cyclophosphamide, or other alkylating agents within 3 months prior to the first dose.(5) Administration of immunosuppressants other than glucocorticoids within 1 month prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, and methotrexate.(6) Receipt of plasma exchange (PE), moderate-volume blood transfusion, or immunomodulatory drugs (e.g., interferon β, interferon γ, or intravenous immunoglobulin [IVIG]) within 1 month prior to the first dose.(7) Performance of thymectomy within 12 months prior to baseline, or a planned thymectomy during the 12-week study period.(8) Comorbidity with other chronic active autoimmune diseases requiring treatment with glucocorticoids, biologics, or immunosuppressants (e.g., rheumatoid arthritis, scleroderma).(9) Vaccination with live or attenuated vaccines within 1 month prior to the first dose.(10) A history of previous bone marrow transplantation, hematopoietic stem cell transplantation, total lymphoid irradiation, or T-cell vaccine therapy.(11) Receipt of any investigational drug within 28 days prior to the first dose or 5 times the half-life of the investigational drug, whichever is shorter.(12) Known hypersensitivity to any component of ripertamab.(13) Pregnant or lactating females; for women of childbearing potential (WOCBP) who have not undergone sterilization: refusal to use appropriate contraceptive methods (e.g., oral contraceptives, intrauterine devices [IUDs], or barrier contraception combined with spermicides) from screening until 6 months after the end of treatment.(14) For males who have not undergone sterilization: refusal to use barrier contraception from screening until 6 months after the end of treatment, and refusal to request their partners to use other contraceptive methods (e.g., oral contraceptives, IUDs, barrier methods, or spermicides).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Drug: ripertamab

On Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered.

Other Name:

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of patients who achieved a reduction of at least 2 points in the MG-ADL score and did not receive rescue therapy at week 13.
Time Frame: week 13
week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongming Qiu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-426

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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