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CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

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ClinicalTrials.gov Identifier: NCT05014724
Expanded Access Status : Available
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Drug: Rozanolixizumab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Rozanolixizumab
    Rozanolixizumab is dosed weekly at 10 mg/kg. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014724


Contacts
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Contact: UCB Cares 0018445992273 UCBCares@ucb.com

Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT05014724    
Other Study ID Numbers: CIDP07
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Rozanolixizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs