Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05014724
Expanded Access Status : Available
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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

Layout table for study information
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)

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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:

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 identifier (NCT number): NCT05014724

Layout table for location contacts
Contact: UCB Cares 0018445992273

Sponsors and Collaborators
UCB Biopharma SRL
Layout table for investigator information
Study Director: UCB Cares 001 844 599 2273 (UCB)
Layout table for additonal information
Responsible Party: UCB Biopharma SRL 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
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs