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NCT05014724 Clinical Trial

CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Clinical Trial

Official title:
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05014724
Other study ID # CIDP07
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2024
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Polyneuropathies
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Biopharma SRL
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Completed NCT02027701 - Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3
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