A Phase 2 interventional study of Rozanolixizumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by UCB Biopharma SRL. Completed at 14 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 2, Interventional, and Treatment
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Among 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States — 20 open to participants now, 25 under way, 10 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · United States.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, this one is the 35th largest by enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2019, is one of 16 in phase 2, and was the 22nd registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →20 of the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States are open now. Recruiting first, the newest first:
Kedrion S.p.A. · Sites in United States
Ages 18+
Kite, A Gilead Company · Sites in United States, Australia, Canada
Ages 18–75
Grifols Therapeutics LLC · Sites in United States, Czechia, Poland and 1 more country
Ages 18+
argenx · Sites in United States, Argentina, Austria and 22 more countries
Ages 18+
argenx · Sites in United States, Argentina, Australia and 28 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 17 · Phase 3 16 · Phase 4 2
First in 1990; this study’s year is marked. 3 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 74 across the 42 interventional studies, 120 across the 12 observational. Of the 28 that completed or were terminated, 14 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under UCB Biopharma SRL, one of the names counted as UCB S.A.. Under that name alone:
UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
UCB S.A. has 3 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
10 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA 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) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT06680037TG Therapeutics, Inc.A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders | 2026-12-01 |
Add all 10 to your calendar (.ics) → With an account.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.
Drug: Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
Time frame: From Baseline until Follow-Up Visit (up to Week 84)
The study started to enroll study participants in Aug 2019 and concluded in Nov 2021.
| Milestone | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) |
|---|---|---|
| Started | 11 | 10 |
| Completed | 3 | 6 |
| Not completed | 8 | 4 |
| Withdrew: Study ending | 1 | 1 |
| Withdrew: Early study termination by participant | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lack of efficacy | 3 | 0 |
| Withdrew: Adverse event, non- fatal | 1 | 1 |
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
| Participants | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Event (TEAEs) | 10 | 10 |
Collected over From Baseline until Follow-Up Visit (up to Week 84). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rozanolixizumab (Newly Treated) | 0/11 (0%) | 2/11 (18.2%) | 10/11 (90.9%) |
| Rozanolixizumab (Previously Treated) | 0/10 (0%) | 2/10 (20%) | 9/10 (90%) |
| Event | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) |
|---|---|---|
| Urinary tract infectionInfections and infestations | 0/11 | 1/10 |
| Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders | 0/11 | 1/10 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/11 | 0/10 |
| Sensory lossNervous system disorders | 1/11 | 0/10 |
| Event | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) |
|---|---|---|
| Blood immunoglobulin G decreasedInvestigations | 4/11 | 4/10 |
| HeadacheNervous system disorders | 4/11 | 1/10 |
| FatigueGeneral disorders | 3/11 | 3/10 |
| ConstipationGastrointestinal disorders | 0/11 | 2/10 |
| NasopharyngitisInfections and infestations | 2/11 | 2/10 |
| Muscle strainInjury, poisoning and procedural complications | 1/11 | 2/10 |
| FallInjury, poisoning and procedural complications | 0/11 | 2/10 |
| Joint swellingMusculoskeletal and connective tissue disorders | 1/11 | 2/10 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/11 | 2/10 |
| NeuralgiaNervous system disorders | 1/11 | 2/10 |
Baseline Characteristics refers to the Safety Set (SS) which consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
| Age, Categorical(Participants) | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 6 | 14 |
| >=65 years | 3 | 4 | 7 |
| Age, Continuous(years) | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| Mean | 59.8 ± 5.1 | 59.1 ± 15.9 | 59.5 ± 11.3 |
| Sex: Female, Male(Participants) | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| White | 8 | 9 | 17 |
| Other/Mixed | 0 | 1 | 1 |
| Missing | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| Not Hispanic or Latino | 9 | 10 | 19 |
| Missing | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data sharing details ↗ · vivli.org
Ran from Aug 2019 to primary completion in Nov 2021, 26 months.
Results were first posted in Nov 2022, 11 months after primary completion.
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Studies of the drug tested here: Rozanolixizumab
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →