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Monoclonal Antibodies
Batoclimab for CIDP
Phase 2
Recruiting
Research Sponsored by Immunovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 12) to week 36
Awards & highlights
Study Summary
This trial tests a drug to treat CIDP, an immune disorder; it includes screening, treatment, and follow-up phases lasting up to 104 weeks. Eligible participants are assigned to one of three cohorts.
Who is the study for?
Adults over 18 with active Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who meet specific diagnostic criteria can join this trial. They should not have other types of polyneuropathies, IgM paraproteinemia, certain forms of CIDP like Distal or Sensory CIDP, poorly controlled diabetes, central demyelination signs, or be on high doses of corticosteroids.Check my eligibility
What is being tested?
The study tests Batoclimab's effectiveness and safety in treating CIDP. Participants will receive either Batoclimab at two different dosages or a placebo via subcutaneous injections for up to one year with various periods including washout and long-term extension phases.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, participants may experience reactions related to subcutaneous injections such as pain at the injection site, redness, swelling, and potential immune-related responses due to the nature of Batoclimab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 12) to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 12) to week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36
Secondary outcome measures
Period 2, Cohort A: Change from Period 2 Baseline in Adj INCAT score
Period 2, Cohort A: Change from Period 2 Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Period 2, Cohort A: Change from Period 2 Baseline in Mean grip strength
+9 moreTrial Design
18Treatment groups
Experimental Treatment
Group I: Withdrawal Period 2: Cohort D, PlaceboExperimental Treatment1 Intervention
Group II: Withdrawal Period 2: Cohort D, Dose 2Experimental Treatment1 Intervention
Group III: Withdrawal Period 2: Cohort C, PlaceboExperimental Treatment1 Intervention
Group IV: Withdrawal Period 2: Cohort C, Dose 2Experimental Treatment2 Interventions
Group V: Withdrawal Period 2: Cohort B, PlaceboExperimental Treatment1 Intervention
Group VI: Withdrawal Period 2: Cohort B, Dose 2Experimental Treatment2 Interventions
Group VII: Withdrawal Period 2: Cohort A, PlaceboExperimental Treatment1 Intervention
Group VIII: Withdrawal Period 2: Cohort A, Dose 2Experimental Treatment2 Interventions
Group IX: Treatment Period 1: Cohort D, Dose 2Experimental Treatment1 Intervention
Group X: Treatment Period 1: Cohort D, Dose 1Experimental Treatment1 Intervention
Group XI: Treatment Period 1: Cohort C, Dose 2Experimental Treatment1 Intervention
Group XII: Treatment Period 1: Cohort C, Dose 1Experimental Treatment1 Intervention
Group XIII: Treatment Period 1: Cohort B, Dose 2Experimental Treatment1 Intervention
Group XIV: Treatment Period 1: Cohort B, Dose 1Experimental Treatment1 Intervention
Group XV: Treatment Period 1: Cohort A, Dose 2Experimental Treatment1 Intervention
Group XVI: Treatment Period 1: Cohort A, Dose 1Experimental Treatment1 Intervention
Group XVII: LTE Period: Without Relapse in Period 2: Dose 2Experimental Treatment1 Intervention
Participants will receive Dose 2 for all 52 weeks.
Group XVIII: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2Experimental Treatment2 Interventions
Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Immunovant Sciences GmbHLead Sponsor
9 Previous Clinical Trials
759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of chronic inflammatory nerve disease.I have been diagnosed with a form of CIDP according to specific guidelines.I have diabetes.My tests show early signs of nerve damage.I am taking prescribed oral corticosteroids regularly.I am 18 years old or older.I have nerve damage not caused by chronic inflammatory demyelinating polyneuropathy.I am 18 years old or older.I have a history of spinal cord disease or central nervous system damage.I have been diagnosed with a form of CIDP according to specific guidelines.I have been diagnosed with CIDP based on clinical and nerve conduction tests.I have been diagnosed with a form of CIDP according to EAN/PNS guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Period 1: Cohort D, Dose 1
- Group 2: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2
- Group 3: Withdrawal Period 2: Cohort A, Placebo
- Group 4: Withdrawal Period 2: Cohort B, Placebo
- Group 5: Treatment Period 1: Cohort A, Dose 2
- Group 6: Treatment Period 1: Cohort D, Dose 2
- Group 7: Withdrawal Period 2: Cohort C, Placebo
- Group 8: Withdrawal Period 2: Cohort D, Dose 2
- Group 9: Withdrawal Period 2: Cohort D, Placebo
- Group 10: LTE Period: Without Relapse in Period 2: Dose 2
- Group 11: Treatment Period 1: Cohort A, Dose 1
- Group 12: Treatment Period 1: Cohort B, Dose 1
- Group 13: Treatment Period 1: Cohort B, Dose 2
- Group 14: Treatment Period 1: Cohort C, Dose 1
- Group 15: Treatment Period 1: Cohort C, Dose 2
- Group 16: Withdrawal Period 2: Cohort A, Dose 2
- Group 17: Withdrawal Period 2: Cohort B, Dose 2
- Group 18: Withdrawal Period 2: Cohort C, Dose 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for participation in this clinical trial currently?
"Based on the information accessible via clinicaltrials.gov, this medical trial is presently enlisting patients; it was originally posted in mid-December 2022 and most recently updated at the end of January 2023."
Answered by AI
Could you elaborate on the potential dangers of Withdrawal Period 2: Cohort A, Dose 2?
"Our team gave Withdrawal Period 2: Cohort A, Dose 2 a safety rating of 2 based on the Phase 2 data available. Although there is evidence for its safe use, efficacy has yet to be established."
Answered by AI
What is the total enrollment capacity for this trial?
"Indeed, the clinicaltrials.gov portal shows that this medical experiment is presently searching for participants. It was first uploaded on December 15th 2022, and lastly modified on January 31st 2023. The study requires 240 subjects from 2 separate sites."
Answered by AI
Who else is applying?
What site did they apply to?
Site Number -1600
Site Number -1601
Site Number - 1629
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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