Phase 3 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Group 1 – People who have not yet been treated:

• People who have been diagnosed with CIDP (a nerve condition) according to recognised international guidelines
• People who have not yet received any treatment for CIDP
• Men and women between 18 and 80 years of age
• People whose CIDP-related disability is considered serious enough by their treating doctor to need the treatments used in this trial
• People who are able to understand and sign a consent form agreeing to take part

Group 2 – People already receiving ongoing treatment:

• People diagnosed with CIDP according to recognised international guidelines who are already on a stable, ongoing treatment schedule (at least 4 infusions or 3 months at the same dose and timing), AND who fall into at least one of these situations:
  • People whose CIDP symptoms return or worsen before their next scheduled infusion, with that change measurable on at least one of the trial's recognised measurement scales
  • People who tried to stop treatment in the last 12 months but were unable to because their condition worsened, with that change measurable on at least one of the trial's recognised measurement scales
  • People whose dose or frequency of treatment was increased in the last 12 months and whose condition then improved, with that improvement measurable on at least one of the trial's recognised measurement scales
• Men and women between 18 and 80 years of age
• People who are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

• People whose nerve condition involves a specific type of antibody known as paranodal antibodies, as this is considered a separate condition from CIDP
• People who have used medications known to cause nerve damage in the last six months
• People who have had a serious reaction to one of the trial treatments in the past, or who are known to be allergic to any ingredient in those treatments
• People who have a specific immune system condition called selective IgA deficiency and who have developed antibodies to IgA
• People whose blood tests show signs of an active or untreated Hepatitis B or Hepatitis C infection
• People currently taking immune-suppressing medication for another health condition
• People who have taken immune-suppressing medication (other than steroids that have already been stopped) in the last six months
• People in Group 2 whose current treatment interval is every six weeks or longer
• People with a body mass index (BMI) over 35
• People with a known active cancer that is not in remission, who are currently receiving chemotherapy or similar treatments, or whose life expectancy is less than one year
• People with a history of repeated or long-lasting infections
• People currently experiencing a serious active infection, such as tuberculosis, blood poisoning, or other severe infections
• People whose immune system is severely weakened
• People with severe heart failure or serious uncontrolled heart disease
• People with other significant health conditions considered serious by their treating doctor
• People who are pregnant, breastfeeding, planning to become pregnant during the study, or who are of childbearing age and are not using or unwilling to use a reliable method of contraception for the full duration of the study
• People who have not provided written consent to participate

Important: Always verify eligibility with the trial site directly before applying.