Recruiting

Observational Study

Sponsor:

Sanofi

Code:

NCT06968975

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic

Study ID

NCT06968975

Start date

Apr 11, 2025

Status verified date

Jul, 2026

Completion date

May 17, 2027

Anticipated

Primary completion date

May 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed
  • Active use of at least one of the following CIDP treatments for three months or longer, with no evidence of discontinuation of this therapy as of the last neurologist visit prior to enrollment

  • immunoglobulin
  • corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day
  • plasma exchange
  • efgartigimod alfa
  • azathioprine
  • mycophenolate mofetil
  • cyclosporine
  • rituximab
  • methotrexate
  • Signed informed consent
  • Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
  • Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
  • Aged under 18 at the time of enrollment

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • I-RODS score at baseline [ Time Frame: Baseline ]
  • Variations of I-RODS score over the study duration [ Time Frame: From Baseline up to End of Study (2 years) ]
  • Variations of I-RODS score after treatment change [ Time Frame: From baseline up to End of Study (approx. 2 years) ]
  • Annualized I-RODS response rate [ Time Frame: Up to End of Study (approx. 2 years) ]
  • Annualized I-RODS relapse rate [ Time Frame: Up to End of Study (approx. 2 years) ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

PicnicHealth For potential study participants

(415) 801-0572orbit-cidp-study@picnichealth.com

Locations

Investigational Site

Recruiting

Swiftwater, Pennsylvania, United States, 18370-0187

More Information

Sponsor

Sanofi

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-24.