Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Conditions
Keywords
Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
Brief summary
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).
Interventions
DRUGRozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01) * Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP) * Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP
Exclusion criteria
* Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject's ability to participate in this study * Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) * Subject has a known hypersensitivity to any components of rozanolixizumab * Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab * Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04 * Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Event (TEAEs) | From Baseline until Follow-Up Visit (up to Week 84) | 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. |
Countries
Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
The study started to enroll study participants in Aug 2019 and concluded in Nov 2021.
Pre-assignment details
Participant Flow refers to the Enrolled Set. Participants from parent study CIDP01 (NCT03861481) who had completed the Treatment Period without a relapse of chronic inflammatory demyelinating polyradiculoneuropathy were directly enrolled into this study. Newly treated participants are participants treated with placebo in parent study CIDP01 (NCT03861481). Previously treated participants are participants treated with rozanolixizumab in parent study CIDP01 (NCT03861481).
Participants by arm
| Arm | Count |
|---|---|
| Rozanolixizumab (Newly Treated) Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 11 |
| Rozanolixizumab (Previously Treated) Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event, non- fatal | 1 | 1 |
| Overall Study | Early study termination by participant | 1 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Study ending | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Rozanolixizumab (Newly Treated) | Rozanolixizumab (Previously Treated) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Continuous | 59.8 years STANDARD_DEVIATION 5.1 | 59.1 years STANDARD_DEVIATION 15.9 | 59.5 years STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 Participants | 10 Participants | 19 Participants |
| Race/Ethnicity, Customized Other/Mixed | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 10 / 11 | 9 / 10 |
| serious Total, serious adverse events | 2 / 11 | 2 / 10 |
Outcome results
Primary
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)
Population: The Safety Set (SS) consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rozanolixizumab (Newly Treated) | Number of Participants With Treatment-emergent Adverse Event (TEAEs) | 10 Participants |
| Rozanolixizumab (Previously Treated) | Number of Participants With Treatment-emergent Adverse Event (TEAEs) | 10 Participants |