Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)NCT05014724
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
A study testing Rozanolixizumab in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by UCB Biopharma SRL.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- Rozanolixizumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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.
- Being tested
- Rozanolixizumab
- Keywords
- Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RozanolixizumabDrug
Rozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014724
- Sponsor's protocol ID
- CIDP07
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
- ClinicalTrials.gov ID
- NCT05014724
- Acronym / sponsor ID
- CIDP07
- Keywords
- Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RozanolixizumabRozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Related trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingObservational study
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP
Not yet recruitingObservational study
Multimodal Characterization of Movement Trajectories in Chronic Inflammatory Demyelinating Polyneuropathy
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingPhase 1
Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment
Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
Questions about this trial
What is this clinical trial studying?
A study testing Rozanolixizumab in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by UCB Biopharma SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.