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
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
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
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
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Primary Completion Date
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Study Completion Date
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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)
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