2023-509370-39-00招募中3 期
An open-label study to investigate the long-term safety and efficacy of belimumab in adults with interstitial lung disease (ILD) associated with systemic sclerosis (SSc) and other connective tissue diseases (CTD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 36
- 主要终点
- Incidence of AEs, AESIs and SAEs
研究概览
简要总结
To describe the long-term safety and tolerability of belimumab treatment in participants with SSc- ILD and other CTD-ILDs
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria: INC#1 o Initiation of new immunosuppressive or immunomodulatory medication for SSc or other CTD-related disease activity/progression since joining study 218224 or
- •o Increase of systemic corticosteroids beyond the allowed limits, for SSc or other CTD-related disease activity/progression since joining study 218224 or 221672 o Discontinuation of study medication during study 218224 or 221672 for any reason.
- •Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh.
- •Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to administer the study medication throughout the study
- •Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: INC#4 o Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Section 10.4: Contraceptive and Barrier Guidance. OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 (Appendix 4: Contraceptive and Barrier Guidance) during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. − A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. See Section 8.3.
- •− If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. − Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.
- •− The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52
- •Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk
- •Participants who have developed any other medical diseases (e.g.., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that, in the opinion of the investigator could significantly alter the absorption, metabolism, or elimination of drugs; constitutes a risk when taking the study intervention; interferes with the interpretation of data; or it is not safe for the participant to continue on the study
- •Participants who have been exposed to ionizing radiation in excess of 10 mSv above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies.
结局指标
主要结局
Incidence of AEs, AESIs and SAEs
Incidence of AEs, AESIs and SAEs
次要结局
- Absolute change from baseline* in FVC (mL) at OLE Weeks 12, 26 and 52.
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (36)
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