A Phase 2 interventional study of Rozanolixizumab and Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by UCB Biopharma S.P.R.L.. Completed at 22 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's enrollment of 34 is close to the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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 will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Drug: Rozanolixizumab
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Other: Placebo
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Subjects will receive placebo in a specified sequence during the treatment period.
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score
iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity.
Time frame: From Baseline up to Week 13 (Day 85)
The study started to enroll study participants in March 2019 and concluded in March 2021.
| Milestone | Placebo | Rozanolixizumab |
|---|---|---|
| Started | 17 | 17 |
| Completed | 11 | 10 |
| Not completed | 6 | 7 |
| Withdrew: Covid-19 pandemic circumstances | 0 | 1 |
| Withdrew: Participant not plan to participate in the study cidp04 | 1 | 0 |
| Withdrew: Relapse | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lack of efficacy | 4 | 5 |
iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity.
| score on a scale (logits) | Placebo | Rozanolixizumab |
|---|---|---|
| Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score | 0.234 ± 0.379 | 0.181 ± 0.468 |
Collected over From Baseline until the Safety Follow-up Visit (up to Week 24). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/17 (0%) | 0/17 (0%) | 14/17 (82.4%) |
| Rozanolixizumab | 0/17 (0%) | 2/17 (11.8%) | 15/17 (88.2%) |
| Event | Placebo | Rozanolixizumab |
|---|---|---|
| Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders | 0/17 | 2/17 |
| Event | Placebo | Rozanolixizumab |
|---|---|---|
| HeadacheNervous system disorders | 5/17 | 6/17 |
| Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders | 4/17 | 4/17 |
| DiarrhoeaGastrointestinal disorders | 3/17 | 2/17 |
| Infusion site erythemaGeneral disorders | 0/17 | 3/17 |
| Peripheral swellingGeneral disorders | 0/17 | 3/17 |
| FatigueGeneral disorders | 3/17 | 0/17 |
| Urinary tract infectionInfections and infestations | 3/17 | 0/17 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/17 | 3/17 |
| NauseaGastrointestinal disorders | 2/17 | 0/17 |
| PainGeneral disorders | 2/17 | 0/17 |
The Randomized Set consisted of all participants randomized into the study.
| Age, Categorical(Participants) | Placebo | Rozanolixizumab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 12 | 28 |
| >=65 years | 1 | 5 | 6 |
| Age, Continuous(years) | Placebo | Rozanolixizumab | Total |
|---|---|---|---|
| Mean | 56.4 ± 7.4 | 57.3 ± 13.3 | 56.8 ± 10.6 |
| Sex: Female, Male(Participants) | Placebo | Rozanolixizumab | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 9 | 9 | 18 |
| Race/Ethnicity, Customized(Participants) | Placebo | Rozanolixizumab | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Black | 1 | 1 | 2 |
| White | 11 | 15 | 26 |
| Other/mixed | 4 | 1 | 5 |
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
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rozanolixizumab
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →