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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05327114




Registration number
NCT05327114
Ethics application status
Date submitted
7/04/2022
Date registered
14/04/2022
Date last updated
9/11/2023

Titles & IDs
Public title
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Scientific title
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Secondary ID [1] 0 0
80202135CDP3001
Secondary ID [2] 0 0
CR109195
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Nipocalimab
Treatment: Drugs - Placebo

Experimental: Nipocalimab - Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.

Placebo Comparator: Placebo - Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.


Treatment: Drugs: Nipocalimab
Nipocalimab will be administered intravenously.

Treatment: Drugs: Placebo
Placebo will be administered intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage B: Time to First Occurrence of a Relapse Event
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Stage A: Percentage of Responders as Determined by ECI
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
Timepoint [3] 0 0
Baseline to 12 weeks
Secondary outcome [4] 0 0
Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
Timepoint [4] 0 0
Baseline to 12 weeks
Secondary outcome [5] 0 0
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
Timepoint [5] 0 0
Baseline to 12 weeks
Secondary outcome [6] 0 0
Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Timepoint [6] 0 0
Baseline to 12 weeks
Secondary outcome [7] 0 0
Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Timepoint [7] 0 0
Baseline to 12 weeks
Secondary outcome [8] 0 0
Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline
Timepoint [8] 0 0
Up to 52 weeks
Secondary outcome [9] 0 0
Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline
Timepoint [9] 0 0
Up to 52 weeks
Secondary outcome [10] 0 0
Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score
Timepoint [10] 0 0
Up to 52 weeks
Secondary outcome [11] 0 0
Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Stage B: Change from Baseline Over Time in I-RODS Centile Score
Timepoint [12] 0 0
Up to 52 weeks
Secondary outcome [13] 0 0
Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Timepoint [13] 0 0
Up to 52 weeks
Secondary outcome [14] 0 0
Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Timepoint [14] 0 0
Up to 52 weeks
Secondary outcome [15] 0 0
Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment
Timepoint [15] 0 0
Up to 52 weeks
Secondary outcome [16] 0 0
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [16] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [17] 0 0
Percentage of Participants with Serious Adverse Events (SAEs)
Timepoint [17] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [18] 0 0
Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
Timepoint [18] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [19] 0 0
Number of Participants with Change in Vital Signs Values Over Time
Timepoint [19] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [20] 0 0
Number of Participants with Change in Clinical Laboratory Values Over Time
Timepoint [20] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [21] 0 0
Number of Participants with Clinically Significant ECG Abnormalities
Timepoint [21] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [22] 0 0
Number of Participants with Clinically Significant Vital Signs Abnormalities
Timepoint [22] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [23] 0 0
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Timepoint [23] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [24] 0 0
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [24] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [25] 0 0
Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention
Timepoint [25] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [26] 0 0
Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
Timepoint [26] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [27] 0 0
Titers of ADA to Nipocalimab
Timepoint [27] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [28] 0 0
Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
Timepoint [28] 0 0
Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary outcome [29] 0 0
Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
Timepoint [29] 0 0
Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks

Eligibility
Key inclusion criteria
- Adults greater than or equal to (>=) 18 years of age at the time of consent and as
applicable, must also meet the legal age of consent in the jurisdiction in which the
study is taking place

- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to
criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021,
progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent
committee during screening period

- Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between
2 and 9 (a score of 2 has to be exclusively from leg disability)

- Fulfilling any of the following treatment conditions: a) Currently treated with pulsed
corticosteroids, oral corticosteroids and/or intravenous immunoglobulin (IVIg) or
subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue or
taper this treatment at the first run-in visit; or b) Without previous treatment
(treatment naive); or treatment with corticosteroids and/or IVIg or SCIg discontinued
at least 3 months prior to screening (untreated)

- Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3

- Other protocol-defined inclusion criteria will apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a history of severe and/or uncontrolled hepatic (example,
viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease),
gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or
musculoskeletal disorder, hypertension and/or any other medical or uncontrolled
autoimmune disorder(s) (example, diabetes mellitus) or clinically significant
abnormalities in screening laboratory that, might interfere with the participants full
participation in the study, or might jeopardize the safety of the participant or the
validity of the study results

- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS
definition)

- Any other disease that could better explain the participant's signs and symptoms, such
as significant persisting neurological deficits from stroke or central nervous system
(CNS) trauma or peripheral neuropathy from another cause such as connective tissue
disease or systemic lupus erythematosus

- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy
(MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated
glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor
neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP);
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change
syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to
diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or
toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes
(example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if
chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main
diagnosis, as determined by the investigator and confirmed by the adjudication
committee

- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients

- Other protocol-defined exclusion criteria will apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Changchun
Country [8] 0 0
China
State/province [8] 0 0
Jinan
Country [9] 0 0
China
State/province [9] 0 0
Nanchang
Country [10] 0 0
China
State/province [10] 0 0
Xi'an
Country [11] 0 0
Czechia
State/province [11] 0 0
Hradec Králové
Country [12] 0 0
Czechia
State/province [12] 0 0
Ostrava
Country [13] 0 0
Czechia
State/province [13] 0 0
Pardubice
Country [14] 0 0
France
State/province [14] 0 0
Bron
Country [15] 0 0
France
State/province [15] 0 0
Le Kremlin Bicêtre
Country [16] 0 0
France
State/province [16] 0 0
Strasbourg
Country [17] 0 0
Japan
State/province [17] 0 0
Asahikawa
Country [18] 0 0
Japan
State/province [18] 0 0
Bunkyo-Ku
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba-shi
Country [20] 0 0
Japan
State/province [20] 0 0
Hamamatsu
Country [21] 0 0
Japan
State/province [21] 0 0
Hyogo
Country [22] 0 0
Japan
State/province [22] 0 0
Isehara
Country [23] 0 0
Japan
State/province [23] 0 0
Koshigaya
Country [24] 0 0
Japan
State/province [24] 0 0
Kumamoto
Country [25] 0 0
Japan
State/province [25] 0 0
Nagoya-shi
Country [26] 0 0
Japan
State/province [26] 0 0
Nagoya
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka-Sayama-shi
Country [28] 0 0
Japan
State/province [28] 0 0
Shimotsuga-gun
Country [29] 0 0
Japan
State/province [29] 0 0
Tenri
Country [30] 0 0
Japan
State/province [30] 0 0
Toyama-shi
Country [31] 0 0
Japan
State/province [31] 0 0
Ube
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Poland
State/province [33] 0 0
Chorzów
Country [34] 0 0
Poland
State/province [34] 0 0
Kraków
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared
to placebo in delaying relapse in adults with chronic inflammatory demyelinating
polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05327114
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05327114