search
Back to results

CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Rozanolixizumab
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) focused on measuring Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • 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

Exclusion Criteria:

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2021
    Last Updated
    November 8, 2022
    Sponsor
    UCB Biopharma SRL
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05014724
    Brief Title
    CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
    Official Title
    CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Biopharma SRL

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Keywords
    Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rozanolixizumab
    Intervention Description
    Rozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria:
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    UCB Cares
    Phone
    0018445992273
    Email
    UCBCares@ucb.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Cares
    Organizational Affiliation
    001 844 599 2273 (UCB)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

    We'll reach out to this number within 24 hrs