To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

January 31, 2024 updated by: Immunovant Sciences GmbH

A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin [Ig] or plasma exchange [PLEX]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

277

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DTP
        • Recruiting
        • Site Number - 7751
    • Tucuman
      • Tucumán, Tucuman, Argentina, T4000AXL
        • Recruiting
        • Site Number - 7752
  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 09000
        • Recruiting
        • Site Number - 4681
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 03000
        • Recruiting
        • Site Number - 4680
  • Bulgaria
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 01606
        • Recruiting
        • Site Number - 9110
  • Denmark
      • Copenhagen, Denmark, 02100
        • Recruiting
        • Site Number - 4740
  • Finland
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Recruiting
        • Site Number - 3241
  • Germany
    • Bayern
      • München, Bayern, Germany, 80337
        • Recruiting
        • Site Number - 6704
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Recruiting
        • Site Number - 6705
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Site Number - 6700
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Site Number - 6702
  • Greece
    • Achaïa
      • Patras, Achaïa, Greece, 265 04
        • Recruiting
        • Site Number -6341
    • Attiki
      • Athens, Attiki, Greece, 11528
        • Recruiting
        • Site Number - 6345
      • Athens, Attiki, Greece, 11525
        • Recruiting
        • Site Number - 6344
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Recruiting
        • Site Number - 6343
    • Irakleio
      • Heraklion, Irakleio, Greece, 71500
        • Recruiting
        • Site Number - 6342
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Site Number - 6300
    • Brescia
      • Gussago, Brescia, Italy, 25084
        • Recruiting
        • Site Number -6302
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40139
        • Recruiting
        • Site Number -6305
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • Recruiting
        • Site Number - 6304
    • Lazio
      • Roma, Lazio, Italy, 00189
        • Recruiting
        • Site Number -6306
      • Roma, Lazio, Italy, 00133
        • Recruiting
        • Site Number - 6309
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Recruiting
        • Site Number - 6301
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • Site Number - 6303
      • Siena, Toscana, Italy, 53100
        • Recruiting
        • Site Number - 6308
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Site Number - 9900
  • Norway
      • Oslo, Norway, 00424
        • Recruiting
        • Site Number -6491
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-556
        • Recruiting
        • Site Number - 3204
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-065
        • Recruiting
        • Site Number - 3211
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-064
        • Recruiting
        • Site Number - 3210
      • Lublin, Lubelskie, Poland, 20-701
        • Recruiting
        • Site Number -3206
      • Mazurki, Lubelskie, Poland, 20-093
        • Recruiting
        • Site Number -3202
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-426
        • Recruiting
        • Site Number -3200
      • Krakow, Malopolskie, Poland, 31-202
        • Recruiting
        • Site Number - 3209
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-803
        • Recruiting
        • Site Number - 3205
    • Slaskie
      • Katowice, Slaskie, Poland, 40-123
        • Recruiting
        • Site Number -3201
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-731
        • Recruiting
        • Site Number - 3207
    • Województwo Kujawsko-pomorskie
      • Bydgoszcz, Województwo Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Site Number -3203
  • Portugal
      • Lisboa, Portugal, 1300-344
        • Recruiting
        • Site Number - 3741
      • Porto, Portugal, 4099-001
        • Recruiting
        • Site Number - 3744
    • Porto
      • Senhora Da Hora, Porto, Portugal, 4464-513
        • Recruiting
        • Site Number - 3742
      • Vila Nova De Gaia, Porto, Portugal, 4434-502
        • Recruiting
        • Site Number - 3745
    • Setubal
      • Almada, Setubal, Portugal, 2805-267
        • Recruiting
        • Site Number - 3743
  • Romania
      • Constanta, Romania, 900591
        • Recruiting
        • SIte Number - 8400
    • Mures
      • Targu Mures, Mures, Romania, 540136
        • Recruiting
        • Site Number - 8401
    • Timis
      • Timişoara, Timis, Romania, 300736
        • Recruiting
        • Site Number - 8403
  • Slovakia
      • Liptovský Mikuláš, Slovakia, 03123
        • Recruiting
        • Site Number - 8600
      • Martin, Slovakia, 036 01
        • Recruiting
        • Site Number - 8601
      • Trnava, Slovakia, 91775
        • Recruiting
        • Site Number - 8602
  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Site Number - 3701
      • Sant Cugat Del Vallès, Barcelona, Spain, 08190
        • Recruiting
        • Site Number - 3704
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spain, 20014
        • Recruiting
        • Site Number -3700
  • Sweden
    • Vastra Gotalands Lan
      • Göteborg, Vastra Gotalands Lan, Sweden, 413 45
        • Recruiting
        • Site Number -4891
  • United Kingdom
      • Manchester, United Kingdom, M6 8HD
        • Recruiting
        • Site Number - 7400
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Site Number - 7405
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Recruiting
        • Site Number - 7403
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85028
        • Recruiting
        • Site Number - 1603
    • California
      • Carlsbad, California, United States, 92011
        • Recruiting
        • Site Number -1618
      • Orange, California, United States, 92868
        • Recruiting
        • Site Number - 1619
      • San Francisco, California, United States, 94109
        • Recruiting
        • Site Number - 1608
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Site Number - 1621
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Site Number - 1630
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • Site Number -1600
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Site Number - 1609
      • Orlando, Florida, United States, 32806-5411
        • Recruiting
        • Site Number - 1629
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Site Number -1617
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Site Number -1620
      • Rockledge, Florida, United States, 32955
        • Recruiting
        • Site Number - 1633
      • Saint Petersburg, Florida, United States, 33713
        • Recruiting
        • Site Number - 1604
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Site Number -1607
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Site Number - 1602
    • Kentucky
      • Nicholasville, Kentucky, United States, 40356
        • Recruiting
        • Site Number - 1611
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Site Number - 1605
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Site Number -1601
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Site Number - 1627

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

All Cohorts:

  1. Are >= 18 years at the Screening Visit.

  2. Have met clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Clinical criteria for typical CIDP and variants are as follows (either criterion must be met):

    1. Typical CIDP: All the following:

      • Progressive or relapsing, symmetric, proximal, and distal muscle weakness of upper and lower limbs, and sensory involvement of at least two limbs (at any point in the disease course)
      • Developing over at least 8 weeks
      • Absent or reduced tendon reflexes in all limbs

    2. CIDP variants: One of the following, but otherwise as in typical CIDP (tendon reflexes may be normal in unaffected limbs):

      • Multifocal CIDP: documented sensory loss and muscle weakness in a multifocal pattern, usually asymmetric, upper limb predominant
      • Focal CIDP: sensory loss and muscle weakness in only one limb
      • Motor CIDP: motor symptoms and signs without sensory involvement

    Cohorts A and B:

  3. Have electrodiagnostic test results supporting the diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP; for Cohorts A and B, either criterion must be met:

    1. Motor nerve conduction criteria strongly supportive of demyelination.

    2. Motor nerve conduction criteria weakly supportive of demyelination and 2 or more of the following additional diagnostic criteria:

      • Objective improvement to an empiric trial of therapy with immunoglobulin treatment, plasma exchange (PLEX), or corticosteroids.
      • Diagnostic imaging by ultrasound or magnetic resonance imaging (MRI) supporting the diagnosis of CIDP by demonstrating nerve enlargement.
      • Cerebrospinal fluid (CSF) demonstrating albuminocytologic dissociation (i.e., elevated CSF protein level [defined as > 70 milligrams per deciliter {mg/dL} or > 10 mg/dL greater than years of age for those aged 60 years and over] with normal CSF white blood cell [WBC] level).
      • Nerve biopsy demonstrating features supporting the diagnosis of CIDP, such as edema, demyelination, and/or onion bulb formation.

    Cohort C only:

  4. Have a diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP based on clinical criteria and motor nerve conduction criteria strongly supportive of demyelination (i.e., motor nerve conduction criteria weakly supportive of demyelination is insufficient diagnostic evidence for admission to Cohort C).

    Cohort D only:

  5. Have met only clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Either inclusion criterion 2(a) or 2(b) must be met.

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

All Cohorts:

  1. Have current or prior history of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
  2. Have Distal CIDP, Sensory CIDP or are suspected of having a diagnosis of auto-immune nodopathy in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP.

  3. Have polyneuropathy of causes other than CIDP including but not limited to:

    1. Multifocal motor neuropathy
    2. Hereditary demyelinating neuropathy
    3. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
    4. Lumbosacral radiculoplexus neuropathy
    5. Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
    6. Drug- or toxin-induced

  4. Have diabetes mellitus (DM) and meets any of the following criteria:

    1. Does not meet inclusion criteria 2(a) and 3(a).
    2. In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
    3. In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
  5. Have a history of myelopathy or evidence of central demyelination.
  6. Are receiving chronic oral corticosteroids monotherapy at a dose > 40 mg/day prednisolone/prednisone or its equivalent at the Screening Visit.
  7. Are receiving chronic oral corticosteroid at a dose > 10 mg/day prednisolone/prednisone or equivalent in combination with immunoglobulin therapy or PLEX at the Screening Visit.

Additional exclusion criteria are defined in the protocol.

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Period 1: Cohort A, Dose 1
Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort A, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort B, Dose 1
Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort B, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort C, Dose 1
Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort C, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Withdrawal Period 2: Cohort A, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Withdrawal Period 2: Cohort B, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Withdrawal Period 2: Cohort C, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort D, Dose 1
Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Treatment Period 1: Cohort D, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Withdrawal Period 2: Cohort A, Placebo
Drug: Placebo
Matching placebo SC
Experimental: Withdrawal Period 2: Cohort B, Placebo
Drug: Placebo
Matching placebo SC
Experimental: Withdrawal Period 2: Cohort C, Placebo
Drug: Placebo
Matching placebo SC
Experimental: Withdrawal Period 2: Cohort D, Dose 2
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Withdrawal Period 2: Cohort D, Placebo
Drug: Placebo
Matching placebo SC
Experimental: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2
Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: LTE Period: Without Relapse in Period 2: Dose 2
Participants will receive Dose 2 for all 52 weeks.
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36
Time Frame: Week 36
Relapse is defined as a worsening (increase) of >=1 point on adjusted inflammatory neuropathy cause and treatment (AdjINCAT) score at any time point during Period 2 relative to Period 2 Baseline which is sustained at a Follow-Up visit 1 week later. The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP. Upper and lower limb dysfunction are each separately assessed on a scale of 0-5 and results are summed together for a total composite score of 0-10. Higher scores represent greater disability. The Adj INCAT disability score is identical to INCAT disability score with exception that changes in upper limb function from 0 (normal) to 1 (minor symptoms) and vice versa are excluded since minor symptoms in the fingers, which are implied by an upper limb score of 1, are not considered clinically significant in all participants. The Adj INCAT disability score will be used for participant selection and measurement of clinical response.
Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Period 2, Cohort A: Time to first relapse relative to Period 2 Baseline
Time Frame: Baseline (Week 12) to Week 36
Baseline (Week 12) to Week 36
Period 2, Cohort A: Change from Period 2 Baseline in Adj INCAT score
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohort A: Change from Period 2 Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Time Frame: Baseline (Week 12) and up to Week 36
The I-RODS for immune-mediated peripheral neuropathies is a patient-based linearly weighted scale that captures activity and social participation limitations in patients with CIDP. The assessment consists of a 24-question instrument that addresses upper and lower limb tasks that range in difficulty from reading a book and eating to standing and running. Answers are scored on a scale of 0-2 (complete disability to no disability) and the raw scores are then transformed into a final score ranging from 0-100.
Baseline (Week 12) and up to Week 36
Period 2, Cohort A: Change from Period 2 Baseline in Mean grip strength
Time Frame: Baseline (Week 12) and up to Week 36
Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment. The Jamar dynamometer and the Martin vigorimeter are both commonly used to assess mean grip strength.
Baseline (Week 12) and up to Week 36
Period 2, Cohort A: Change from Period 2 Baseline in Medical Research Council (MRC) Sum Score
Time Frame: Baseline (Week 12) and up to Week 36
The MRC sum score is a standardized methodology for objectively assessing and reporting muscle function. Six muscle groups are assessed bilaterally, and each scored on a scale of 0 (no visible contraction) to 5 (normal) yielding a sum ranging from 0 (paralysis) to 60 (normal strength). Higher scores indicate normal muscle strength.
Baseline (Week 12) and up to Week 36
Period 2, Cohort A: Change from Period 2 Baseline in Overall Neuropathy Limitations Scale (ONLS)
Time Frame: Baseline (Week 12) and up to Week 36
The ONLS is a scale that focuses on upper and lower limb functions and was designed to assess the limitations of participants with immune-mediated peripheral neuropathies. This scale is completed by adding the total of the arm grade from zero point (less limitation) to 5 points (most limitation) and leg grade from zero point (less limitation) to 7 points (more limitation) yielding a total score of 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition.
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Adj INCAT score
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A and B combined: Change from Period 2 Baseline in I-RODS
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Mean Grip Strength
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A and B combined: Change from Period 2 Baseline in MRC sum score
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A and B combined: Change from Period 2 Baseline in ONLS
Time Frame: Baseline (Week 12) and up to Week 36
Baseline (Week 12) and up to Week 36
Period 2, Cohorts A, B, and C: Proportion of participants who remain relapse-free at Week 36
Time Frame: Week 36
Week 36

Collaborators and Investigators

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

Sponsor

Immunovant Sciences GmbH

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 (Actual)

December 15, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1401-2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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