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New hope for nerve disease: batoclimab safety trial expands

NCT ID NCT07188844

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study checks the long-term safety of a drug called batoclimab for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a nerve disorder that causes weakness and numbness. About 108 people who finished an earlier batoclimab study will get weekly injections for up to a year. Researchers will watch for side effects and measure how well the drug controls the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Aug 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Any participant who has completed Study IMVT-1401-2401 * Female participants of childbearing potential must agree to use a highly effective method of birth control * Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration * Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration * Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration * Agree not to participate in another interventional study while on treatment Exclusion Criteria: * Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study. * Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab * Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402 * Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401 Note: Other protocol specified criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Site Number - 1601

    Austin, Texas, 78759, United States

  • Site Number - 1610

    Charlotte, North Carolina, 28207, United States

  • Site Number - 1611

    Nicholasville, Kentucky, 40356, United States

  • Site Number - 1617

    Ormond Beach, Florida, 32174, United States

  • Site Number - 1621

    New Haven, Connecticut, 06519, United States

  • Site Number - 3201

    Katowice, Silesian Voivodeship, 40-123, Poland

  • Site Number - 3206

    Lublin, Lublin Voivodeship, 20-701, Poland

  • Site Number - 3207

    Poznan, Greater Poland Voivodeship, 61-731, Poland

  • Site Number - 3208

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Site Number - 3209

    Krakow, Lesser Poland Voivodeship, 31-202, Poland

  • Site Number - 3210

    Lublin, Lublin Voivodeship, 20-064, Poland

  • Site Number - 4680

    Leuven, Vlaams Brabant, 3000, Belgium

  • Site Number - 6305

    Bologna, Emilia-Romagna, 40139, Italy

  • Site Number - 6307

    Milan, Lombardy, 20132, Italy

  • Site Number - 6309

    Rome, Lazio, 00133, Italy

  • Site Number - 6341

    Pátrai, Achaïa, 265 04, Greece

  • Site Number - 6344

    Athens, Attica, 115 25, Greece

  • Site Number - 6347

    Larissa, 41110, Greece

  • Site Number - 6702

    Leipzig, Saxony, 04103, Germany

  • Site Number - 7750

    Buenos Aires, C1199ABB, Argentina

  • Site Number - 7751

    Rosario, Santa Fe Province, S2000DTP, Argentina

  • Site Number - 7752

    San Miguel de Tucumán, T4000AXL, Argentina

  • Site Number - 7753

    Rosario, Santa Fe Province, S2000BZL, Argentina

  • Site Number - 8400

    Constanța, 900591, Romania

  • Site Number - 8403

    Timișoara, Timiș County, 300736, Romania

  • Site Number - 8501

    Belgrade, 11000, Serbia

  • Site Number - 8603

    Prešov, 081 81, Slovakia

  • Site Number - 9100

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Site Number - 9101

    Curitiba, Paraná, 81210-310, Brazil

  • Site Number - 9103

    Brasília, Federal District, 70200-730, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.