Chronic Inflammatory Demyelinating PolyneuropathyPhase 2NCT07188844
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2 study testing Batoclimab in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 30 sites in 11 countries.
Trial summary
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Batoclimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 30 sitesin 11 countries
- Study dates
- 28 Aug 2025to 16 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
30 sites in 11 countries.
30 sites in 11 countries
Poland6 sites
Site Number - 3201
Katowice, Silesian Voivodeship, 40-123
Site Number - 3208
Krakow, Lesser Poland Voivodeship, 30-688
Site Number - 3209
Krakow, Lesser Poland Voivodeship, 31-202
Site Number - 3210
Lublin, Lublin Voivodeship, 20-064
Site Number - 3206
Lublin, Lublin Voivodeship, 20-701
Site Number - 3207
Poznan, Greater Poland Voivodeship, 61-731
United States5 sites
Site Number - 1601
Austin, Texas, 78759
Site Number - 1610
Charlotte, North Carolina, 28207
Site Number - 1621
New Haven, Connecticut, 06519
Site Number - 1611
Nicholasville, Kentucky, 40356
Site Number - 1617
Ormond Beach, Florida, 32174
Argentina4 sites
Site Number - 7750
Buenos Aires, C1199ABB
Site Number - 7753
Rosario, Santa Fe Province, S2000BZL
Site Number - 7751
Rosario, Santa Fe Province, S2000DTP
Site Number - 7752
San Miguel de Tucumán, T4000AXL
Brazil3 sites
Site Number - 9103
Brasília, Federal District, 70200-730
Site Number - 9101
Curitiba, Paraná, 81210-310
Site Number - 9100
Ribeirão Preto, São Paulo, 14048-900
Greece3 sites
Site Number - 6344
Athens, Attica, 115 25
Site Number - 6347
Larissa, 41110
Site Number - 6341
Pátrai, Achaïa, 265 04
Italy3 sites
Site Number - 6305
Bologna, Emilia-Romagna, 40139
Site Number - 6307
Milan, Lombardy, 20132
Site Number - 6309
Rome, Lazio, 00133
Romania2 sites
Site Number - 8400
Constanța, 900591
Site Number - 8403
Timișoara, Timiș County, 300736
About this study
Official title: An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
- Being tested
- Batoclimab
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Batoclimab
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BatoclimabDrug
Also called IMVT-1401
Batoclimab 340 mg SC QW
| Study group | Role | What they receive |
|---|---|---|
| Batoclimab | Experimental | Not described Receives: Drug: Batoclimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
Measured: Up to 52 weeks
Secondary outcomes (2)
Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)
The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP and will be used for measurement of clinical response.
Measured: Up to 52 weeks
Change from Baseline in Mean Grip Strength
Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start28 Aug 2025
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188844
- Sponsor's protocol ID
- IMVT-1401-2402
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT07188844
- Acronym / sponsor ID
- IMVT-1401-2402
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Batoclimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Batoclimab | Experimental | Drug: Batoclimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BatoclimabAlso: IMVT-1401Batoclimab 340 mg SC QW | Drug | Batoclimab |
Primary outcome
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
Time frame: Up to 52 weeks
2 secondary outcomes
Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)
Time frame: Up to 52 weeks
Change from Baseline in Mean Grip Strength
Time frame: Up to 52 weeks
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Batoclimab in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 30 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Poland, United States, Argentina, Brazil, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.