Trial · NCT05084053
A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)
NCT05084053, Phase 3, Completed, Takeda; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN). Trials, record NCT05084053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05084053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)
- NCT number
- NCT05084053
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Multifocal Motor Neuropathy (MMN)
- Interventions
- TAK-771
- First posted
- 2021-10-19
- Last updated
- 2026-06-24
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse | Epoch 1: Baseline up to 6 months | Relapse was defined as worsening of functional disability defined as an increase of \>=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function. |
| Primary | Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN | Epoch 1: Baseline up to 6 months | The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kilopascal (kPa) ranging from 0 to 160 kPa. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | TEAEs were defined as adverse events that occurred during or after administration of the first dose of investigational product (IP). TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAEs were defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, or any other important medical event. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Infusion associated SAEs and/or TEAEs were defined as SAEs and/or TEAEs considered to be "infusion-related reactions" by investigators. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. SAEs and TEAEs associated with infusions were the events considered to be "infusion-related reactions" by investigators. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With TEAEs Temporally Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP. TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). TEAEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion. |
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. AEs temporally associated with infusions are defined as AEs occurring during or within 72 hours after completion of an infusion. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse | Epoch 1: Baseline up to 6 months | FAS included all enrolled participants who received TAK-771 at least once. | percentage of participants | NUMBER |
| PRIMARY | Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN | Epoch 1: Baseline up to 6 months | FAS included all enrolled participants who received TAK-771 at least once. | kPa | MEAN |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Safety analysis set (SAS)included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With TEAEs Temporally Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | SAS included all enrolled participants who received TAK-771 administration at least once. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group83
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse | Epoch 1, Cohort 1 (CIDP): TAK-771 | 0 | 95% Confidence Interval 0.00 to 17.65 | percentage of participants | |
| Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN | Epoch 1, Cohort 2 (MMN): TAK-771 | -1.1 | Standard Deviation 12.73 | kPa | |
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 1, Cohort 1 (CIDP): TAK-771 | 16 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 1, Cohort 2 (MMN): TAK-771 | 7 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 11 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 6 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 1, Cohort 1 (CIDP): TAK-771 | 0 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 1, Cohort 2 (MMN): TAK-771 | 0 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | Participants | ||
| Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 0 | Participants |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Epoch 1: Up to 6 months | STARTED | Epoch 1, Cohort 1 (CIDP): TAK-771 | 19 | |
| Epoch 1: Up to 6 months | STARTED | Epoch 1, Cohort 2 (MMN): TAK-771 | 7 | |
| Epoch 1: Up to 6 months | STARTED | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | |
| Epoch 1: Up to 6 months | STARTED | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 0 | |
| Epoch 1: Up to 6 months | Treated | Epoch 1, Cohort 1 (CIDP): TAK-771 | 19 | |
| Epoch 1: Up to 6 months | Treated | Epoch 1, Cohort 2 (MMN): TAK-771 | 7 | |
| Epoch 1: Up to 6 months | Treated | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | |
| Epoch 1: Up to 6 months | Treated | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 0 | |
| Epoch 1: Up to 6 months | COMPLETED | Epoch 1, Cohort 1 (CIDP): TAK-771 | 17 | |
| Epoch 1: Up to 6 months | COMPLETED | Epoch 1, Cohort 2 (MMN): TAK-771 | 7 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events268
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Epoch 1, Cohort 1 (CIDP): TAK-771 | 0 | 19 | |
| other | Abdominal distension | Gastrointestinal disorders | Epoch 1, Cohort 2 (MMN): TAK-771 | 1 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 1 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Epoch 1, Cohort 1 (CIDP): TAK-771 | 1 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | Epoch 1, Cohort 2 (MMN): TAK-771 | 0 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | 16 | |
| other | Abdominal pain | Gastrointestinal disorders | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 0 | 7 | |
| other | Administration site erythema | General disorders and administration site conditions | Epoch 1, Cohort 1 (CIDP): TAK-771 | 1 | 19 | |
| other | Administration site erythema | General disorders and administration site conditions | Epoch 1, Cohort 2 (MMN): TAK-771 | 1 | 7 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epoch 1, Cohort 1 (CIDP): TAK-771 | 0 | 19 |
| Total, all-cause mortality | Epoch 1, Cohort 2 (MMN): TAK-771 | 0 | 7 |
| Total, all-cause mortality | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 0 | 16 |
| Total, all-cause mortality | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 0 | 7 |
| Total, other adverse events | Epoch 1, Cohort 1 (CIDP): TAK-771 | 16 | 19 |
| Total, other adverse events | Epoch 1, Cohort 2 (MMN): TAK-771 | 7 | 7 |
| Total, other adverse events | Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 | 11 | 16 |
| Total, other adverse events | Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 | 6 | 7 |
| Total, serious adverse events | Epoch 1, Cohort 1 (CIDP): TAK-771 | 0 | 19 |
| Total, serious adverse events | Epoch 1, Cohort 2 (MMN): TAK-771 | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05084053
GET https://conductscience.org/api/trials/v1/NCT05084053/results?page=2