chronic inflammatory demyelinating polyneuropathy
Conditions
Interventions
Test group:The subjects received one dose of 300 mg/2 mL PFP SC injection of riliprubart once a week.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants with CIDP currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, or Study EFC18156. (Participants receiving riliprubart in Part C of PDY16744 are eligible after completing the Part C EOT visit.); 2. All participants must agree to use contraception methods during and after the study as required. Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants A male participant is eligible to participate if he agrees to the following during the study intervention period and for at least 55 weeks after the last dose of study medication. • Refrain from donating or cryopreserving sperm. • PLUS, either: • Be abstinent from heterosexual intercourse (abstinent on a long term and persistent basis) and agree to remain abstinent OR • Must agree to use contraception/barrier when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant as detailed below: A male condom and an additional highly effective contraceptive method as described in Appendix 10.4 (Section ?10.4 Contraceptive and barrier guidance). b. Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: • Is a woman of nonchildbearing potential as defined in Appendix 10.4 (Section ?10.4 Contraceptive and barrier guidance). OR • Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of 30 IU/L and amenorrhea with no alternative medical cause for at least 12 months. 3. Participant must be capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation; 2. Clinical diagnosis of systemic lupus erythematosus (SLE). 3. History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody. 4. Any country-related specific regulation that would prevent the participant from entering the study – see Appendix 8 (Section ?10.8 Country-specific requirements). 5. Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized; 6. Unsuitability for participation as judged by the Investigator, whatever the reason, including: medical or clinical condition (eg, clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric, or other major systemic disease, including malignancies), potential risk of participant noncompliance with study procedures, or any other clinically significant change in the participants’ medical condition that in the judgment of the Investigator may affect the participant’s safety as a result of participation in this extension study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormaliti; | — |
Countries
China
Contacts
Public ContactJie Lin
Huashan Hospital, Fudan University
Outcome results
None listed