New hope for nerve disease: batoclimab safety trial expands
NCT ID NCT07188844
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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26 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Jul 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Site Number - 1601
Austin, Texas, 78759, United States
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Site Number - 1610
Charlotte, North Carolina, 28207, United States
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Site Number - 1611
Nicholasville, Kentucky, 40356, United States
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Site Number - 1617
Ormond Beach, Florida, 32174, United States
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Site Number - 1621
New Haven, Connecticut, 06519, United States
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Site Number - 3201
Katowice, Silesian Voivodeship, 40-123, Poland
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Site Number - 3206
Lublin, Lublin Voivodeship, 20-701, Poland
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Site Number - 3207
Poznan, Greater Poland Voivodeship, 61-731, Poland
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Site Number - 3208
Krakow, Lesser Poland Voivodeship, 30-688, Poland
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Site Number - 3209
Krakow, Lesser Poland Voivodeship, 31-202, Poland
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Site Number - 3210
Lublin, Lublin Voivodeship, 20-064, Poland
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Site Number - 4680
Leuven, Vlaams Brabant, 3000, Belgium
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Site Number - 6305
Bologna, Emilia-Romagna, 40139, Italy
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Site Number - 6307
Milan, Lombardy, 20132, Italy
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Site Number - 6309
Rome, Lazio, 00133, Italy
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Site Number - 6341
Pátrai, Achaïa, 265 04, Greece
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Site Number - 6344
Athens, Attica, 115 25, Greece
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Site Number - 6347
Larissa, 41110, Greece
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Site Number - 6702
Leipzig, Saxony, 04103, Germany
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Site Number - 7750
Buenos Aires, C1199ABB, Argentina
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Site Number - 7751
Rosario, Santa Fe Province, S2000DTP, Argentina
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Site Number - 7752
San Miguel de Tucumán, T4000AXL, Argentina
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Site Number - 7753
Rosario, Santa Fe Province, S2000BZL, Argentina
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Site Number - 8400
Constanța, 900591, Romania
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Site Number - 8403
Timișoara, Timiș County, 300736, Romania
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Site Number - 8501
Belgrade, 11000, Serbia
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Site Number - 8603
Prešov, 081 81, Slovakia
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Site Number - 9100
Ribeirão Preto, São Paulo, 14048-900, Brazil
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Site Number - 9101
Curitiba, Paraná, 81210-310, Brazil
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Site Number - 9103
Brasília, Federal District, 70200-730, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ultrasound probes nerve stiffness in rare nerve diseases
- Can a new antibody calm the immune attack in CIDP?
- Could a simple blood test track nerve damage? a study investigates NT-3 levels in neuropathy.
- New drug mimics natural protein to calm overactive immune system in nerve disease
- Shocking muscles to move: new exercise hope for nerve disease patients
- Could a stem cell transplant stop the immune system from attacking the brain?