NCT05014724

Brief Summary

This Post Trial Access (PTA) Program enables access to rozanolixizumab for eligible patients who have taken part in the CIDP04 trial (NCT04051944) and are continuing to derive benefit from treatment.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

First QC Date

August 19, 2021

Last Update Submit

January 23, 2024

Conditions

Keywords

Chronic inflammatory demyelinating polyradiculoneuropathyCIDPUCB7665rozanolixizumab

Interventions

Rozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who has taken part in the CIDP04 (NCT04051944) study
  • Patient who derives continued benefit from treatment
  • All required safety information has been reported as per local laws/regulations, reported to Bionical, as appropriate, and documented in the patient's medical records
  • Patient is not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

rozanolixizumab

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • UCB Cares

    001 844 599 2273 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 20, 2021

Last Updated

January 25, 2024

Record last verified: 2024-01