AzTrials
AzTrials

Chronic Inflammatory Demyelinating PolyneuropathyPhase 2NCT05581199

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

A Phase 2 study testing Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly and Batoclimab 340 mg SC weekly in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 98 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly and Batoclimab 340 mg SC weekly
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
98 sitesin 21 countries
Study dates
15 Dec 2022to 20 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

  • All Cohorts:
  • Are >= 18 years at the Screening Visit.
  • 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):
  • 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
Show all 24Show fewer
  • Absent or reduced tendon reflexes in all limbs
  • 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:
  • 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:
  • Motor nerve conduction criteria strongly supportive of demyelination.
  • 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:
  • 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:
  • 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.

Who cannot join

  • All Cohorts:
  • Have current or prior history of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
  • 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.
  • Have polyneuropathy of causes other than CIDP including but not limited to:
  • Multifocal motor neuropathy
  • Hereditary demyelinating neuropathy
Show all 18Show fewer
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
  • Lumbosacral radiculoplexus neuropathy
  • Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
  • Drug- or toxin-induced
  • Have diabetes mellitus (DM) and meets any of the following criteria:
  • Does not meet inclusion criteria 2(a) and 3(a).
  • In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
  • In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
  • Have a history of myelopathy or evidence of central demyelination.
  • Are receiving chronic oral corticosteroids monotherapy at a dose > 40 mg/day prednisolone/prednisone or its equivalent at the Screening Visit.
  • 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.

Trial locations and contacts

98 sites in 21 countries.

98 sites in 21 countries

United States21 sites

  • Site Number - 1625

    Aurora, Colorado, 80045

  • Site Number -1601

    Austin, Texas, 78759

  • Site Number - 1610

    Charlotte, North Carolina, 28207

  • Site Number - 1606

    Houston, Texas, 77030

  • Site Number - 1602

    Kansas City, Kansas, 66160

  • Site Number - 1634

    Los Angeles, California, 90033-5330

  • Site Number - 1613

    Milwaukee, Wisconsin, 53226-3548

  • Site Number - 1621

    New Haven, Connecticut, 06519

  • Site Number - 1605

    New York, New York, 10032

  • Site Number - 1611

    Nicholasville, Kentucky, 40356

  • Site Number - 1629

    Orlando, Florida, 32806-5411

  • Site Number - 1617

    Ormond Beach, Florida, 32174

  • Site Number - 1623

    Philadelphia, Pennsylvania, 19104

  • Site Number - 1624

    Philadelphia, Pennsylvania, 19104

  • Site Number - 1620

    Port Charlotte, Florida, 33952

  • Site Number - 1614

    Portland, Oregon, 97239

  • Site Number - 1633

    Rockledge, Florida, 32955

  • Site Number - 1628

    San Antonio, Texas, 78229

  • Site Number - 1603

    Scottsdale, Arizona, 85028

  • Site Number - 1632

    Seattle, Washington, 98195-0001

  • Site Number - 1604

    St. Petersburg, Florida, 33713

Other trials in United States

Poland10 sites

  • Site Number - 3211

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065

  • Site Number - 3203

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Site Number - 3205

    Gdansk, Pomeranian Voivodeship, 80-803

  • 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 - 3202

    Mazurki, Lublin Voivodeship, 20-093

  • Site Number - 3207

    Poznan, Greater Poland Voivodeship, 61-731

Other trials in Poland

Italy9 sites

  • Site Number - 6301

    Bergamo, Lombardy, 24127

  • Site Number - 6305

    Bologna, Emilia-Romagna, 40139

  • Site Number - 6302

    Gussago, Brescia, 25084

  • Site Number - 6307

    Milan, Lombardy, 20132

  • Site Number - 6300

    Pavia, 27100

  • Site Number - 6303

    Pisa, Tuscany, 56126

  • Site Number - 6309

    Rome, Lazio, 00133

  • Site Number - 6306

    Rome, Lazio, 00189

  • Site Number - 6308

    Siena, Tuscany, 53100

Other trials in Italy

Greece7 sites

  • Site Number - 6343

    Alexandroupoli, Evros, 68100

  • Site Number - 6344

    Athens, Attica, 115 25

  • Site Number - 6345

    Athens, Attica, 115 28

  • Site Number - 6342

    Heraklion, Irakleio, 715 00

  • Site Number - 6346

    Ioannina, 455 00

  • Site Number - 6347

    Larissa, 41110

  • Site Number - 6341

    Pátrai, Achaïa, 265 04

Other trials in Greece

United Kingdom6 sites

  • Site Number - 7405

    Cambridge, Cambridgeshire, CB2 0QQ

  • Site Number - 7404

    Glasgow, Lanarkshire, G51 4TF

  • Site Number - 7400

    Manchester, M6 8HD

  • Site Number - 7403

    Preston, Lancashire, PR2 9HT

  • Site Number - 7401

    Sheffield, South Yorkshire, S10 2JF

  • Site Number - 7402

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Portugal5 sites

  • Site Number - 3743

    Almada, Setúbal District, 2805-267

  • Site Number - 3741

    Lisbon, 1300-344

  • Site Number - 3744

    Porto, 4099-001

  • Site Number - 3742

    Senhora da Hora, Porto District, 4464-513

  • Site Number - 3745

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

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, Tucumán Province, T4000AXL

Other trials in Argentina

Brazil4 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

  • Site Number - 9105

    São Paulo, 01409-000

Other trials in Brazil

Romania4 sites

  • Site Number - 8406

    Bucharest, Bucharest, 41914

  • SIte Number - 8400

    Constanța, 900591

  • Site Number - 8401

    Târgu Mureş, Mureș County, 540136

  • Site Number - 8403

    Timișoara, Timiș County, 300736

Other trials in Romania

Serbia4 sites

  • Site Number - 8501

    Belgrade, 11000

  • Site Number - 8502

    Belgrade, 11000

  • Site Number - 8500

    Niš, 18000

  • Site Number - 8503

    Novi Sad, 21000

Other trials in Serbia

Slovakia4 sites

  • Site Number - 8600

    Liptovský Mikuláš, 031 23

  • Site Number - 8601

    Martin, 036 01

  • Site Number - 8603

    Prešov, 081 81

  • Site Number - 8602

    Trnava, 91775

Other trials in Slovakia

Spain4 sites

  • Site Number - 3703

    Barcelona, 08025

  • Site Number - 3701

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Site Number - 3700

    San Sebastián, Gipuzkoa, 20014

  • Site Number - 3704

    Sant Cugat del Vallès, Barcelona, 08190

Other trials in Spain

Bulgaria3 sites

  • Site Number - 9112

    Pleven, 05800

  • Site Number - 9111

    Sofia, Sofia-Grad, 01527

  • Site Number - 9110

    Sofia, Sofia-Grad, 01606

Other trials in Bulgaria

Germany3 sites

  • Site Number - 6706

    Berlin, 10117

  • Site Number - 6705

    Bochum, North Rhine-Westphalia, 44791

  • Site Number - 6702

    Leipzig, Saxony, 04103

Other trials in Germany

Belgium2 sites

  • Site Number - 4681

    Ghent, Oost-Vlaanderen, 09000

  • Site Number - 4680

    Leuven, Vlaams Brabant, 03000

Other trials in Belgium

Canada2 sites

  • Site Number - 2600

    Edmonton, Alberta, T6J 1M3

  • Site Number - 2603

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

South Korea2 sites

  • Site Number - 9901

    Seoul, 02841

  • Site Number - 9900

    Seoul, 06351

Other trials in South Korea

Denmark1 site

  • Site Number - 4740

    Copenhagen, 02100

Other trials in Denmark

Finland1 site

  • Site Number - 3241

    Turku, Southwest Finland, 20520

Other trials in Finland

Norway1 site

  • Site Number - 6491

    Oslo, 00424

Other trials in Norway

Sweden1 site

  • Site Number - 4891

    Gothenburg, Västra Götaland County, 413 45

Other trials in Sweden

About this study

Official title: 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.

Being tested
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly, Batoclimab 340 mg SC weekly, Placebo
Keywords
Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1401, Monoclonal antibody, Autoimmune disorders
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.

  • Batoclimab 680 milligrams (mg) subcutaneous (SC) weeklyDrug

    Also called IMVT-1401

    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

  • Batoclimab 340 mg SC weeklyDrug

    Also called IMVT-1401

    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

  • PlaceboDrug

    Matching placebo SC

Study groups in NCT05581199
Study groupRoleWhat they receive
Treatment Period 1: Cohort A, Dose 1ExperimentalNot described
Receives: Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Treatment Period 1: Cohort A, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Treatment Period 1: Cohort B, Dose 1ExperimentalNot described
Receives: Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Treatment Period 1: Cohort B, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Treatment Period 1: Cohort C, Dose 1ExperimentalNot described
Receives: Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Treatment Period 1: Cohort C, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Treatment Period 1: Cohort D, Dose 1ExperimentalNot described
Receives: Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Treatment Period 1: Cohort D, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Withdrawal Period 2: Cohort A, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Withdrawal Period 2: Cohort A, PlaceboExperimentalNot described
Receives: Drug: Placebo
Withdrawal Period 2: Cohort B, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Withdrawal Period 2: Cohort B, PlaceboExperimentalNot described
Receives: Drug: Placebo
Withdrawal Period 2: Cohort C, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Withdrawal Period 2: Cohort C, PlaceboExperimentalNot described
Receives: Drug: Placebo
Withdrawal Period 2: Cohort D, Dose 2ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Withdrawal Period 2: Cohort D, PlaceboExperimentalNot described
Receives: Drug: Placebo
LTE Period: With Relapse in Period 2: Dose 1 and Dose 2ExperimentalParticipants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Receives: Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly; Drug: Batoclimab 340 mg SC weekly
LTE Period: Without Relapse in Period 2: Dose 2ExperimentalParticipants will receive Dose 2 for all 52 weeks.
Receives: Drug: Batoclimab 340 mg SC weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Period 2, Cohort A: Proportion of participants who remain relapse-free at 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.

    Measured: Week 36

Secondary outcomes (12)

  1. Period 2, Cohort A: Time to first relapse relative to Period 2 Baseline

    Measured: Baseline (Week 12) to Week 36

  2. Period 2, Cohort A: Change from Period 2 Baseline in Adj INCAT score

    Measured: Baseline (Week 12) and up to Week 36

  3. Period 2, Cohort A: Change from Period 2 Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS)

    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.

    Measured: Baseline (Week 12) and up to Week 36

  4. Period 2, Cohort A: Change from Period 2 Baseline in Mean grip strength

    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.

    Measured: Baseline (Week 12) and up to Week 36

  5. Period 2, Cohort A: Change from Period 2 Baseline in Medical Research Council (MRC) Sum Score

    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.

    Measured: Baseline (Week 12) and up to Week 36

  6. Period 2, Cohort A: Change from Period 2 Baseline in Overall Neuropathy Limitations Scale (ONLS)

    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.

    Measured: Baseline (Week 12) and up to Week 36

  7. Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Adj INCAT score

    Measured: Baseline (Week 12) and up to Week 36

  8. Period 2, Cohorts A and B combined: Change from Period 2 Baseline in I-RODS

    Measured: Baseline (Week 12) and up to Week 36

  9. Period 2, Cohorts A and B combined: Change from Period 2 Baseline in Mean Grip Strength

    Measured: Baseline (Week 12) and up to Week 36

  10. Period 2, Cohorts A and B combined: Change from Period 2 Baseline in MRC sum score

    Measured: Baseline (Week 12) and up to Week 36

  11. Period 2, Cohorts A and B combined: Change from Period 2 Baseline in ONLS

    Measured: Baseline (Week 12) and up to Week 36

  12. Period 2, Cohorts A, B, and C: Proportion of participants who remain relapse-free at Week 36

    Measured: Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start15 Dec 2022
  3. Primary completion20 Jul 2026
  4. Study completion20 Jul 2026

Why it stopped: Sponsor Decision

Resources

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
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581199
Sponsor's protocol ID
IMVT-1401-2401
Status last verified
Aug 2026
First submitted
12 Oct 2022
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly and Batoclimab 340 mg SC weekly in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 98 sites in 21 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 24 inclusion and 18 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 98 sites in United States, Poland, Italy, Greece, United Kingdom and 16 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?

Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36 (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581199.

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.

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