EUCTR2018-004244-33-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female patients aged =18 to =70 years inclusive at time of informed consent
- •2. Diagnosis of pulmonary sarcoidosis for =6 months (cutaneous and ocular involvement allowed), defined as:
- •Histologically proven diagnosis of sarcoidosis by bronchoscopy, biopsy (any organ) or bronchioalveolar lavage.
- •Evidence of parenchymal lung involvement by historical radiological evidence (eg, computed tomography [CT], magnetic resonance imaging [MRI], 18F-FDG PET/CT or chest X-ray) or on the Screening 18F-FDG PET/CT.
- •3. Must have symptomatic and/or active pulmonary sarcoidosis as evidence by:
- •Clinical findings of dyspnea, as indicated by a Modified Medical Research Council (MRC) Dyspnea Scale grade of at least 1; and
- •FVC% predicted =50%; and
- •Positive 18F-FDG PET/CT scan showing increased metabolic activity (maximum standardized update value [SUVmax] >1) in lung parenchyma within 4 weeks prior to Day 1.
- •4. Must be receiving treatment with 10 to 25 mg/day of oral prednisone (or oral equivalent; eg, methylprednisolone), at a stable dose for =4 weeks prior to Day 1, and be determined by the Investigator to be capable of undergoing the protocol-specified steroid taper regimen.
- •Treatment with one oral immunomodulatory therapy (eg, methotrexate, azathioprine, hydroxychloroquine) at a stable dose for =1 months prior to Day 1 is allowed but not required. The dose of this therapy should remain constant throughout the study.
- •5. Body weight =45 kg and <160 kg.
- •6. Female patients may be of childbearing potential or of non-childbearing potential (either surgically sterilized or at least 1 year postmenopausal (confirmed by amenorrhea duration of at least 12 months and serum follicle-stimulating hormone [FSH] =30 mIU/mL).
- •Female patients of childbearing potential must be non-pregnant and non-lactating, and have a negative pregnancy test at Screening (serum) and at Day 1 (urine) prior to first study drug infusion.
- •Additionally, female patients of childbearing potential must be willing to use highly-effective contraception from Screening until 90 days after the last follow-up visit.
- •7. Male patients, if not infertile or surgically sterilized, must agree to use highly-effective contraception and not donate sperm from Screening until 90 days after the last follow-up visit.
- •8. Provision of written informed consent.
- •9. Be able to communicate well with the Investigator and site personnel, and agree to comply with all study procedures and requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Current disease presentation consistent with Lofgren’s syndrome (ie, presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).
- •2. History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to ATYR1923 or to its inactive components (L histidine, sodium chloride, sucrose, L-methionine, and polysorbate-20).
- •3. Treatment (within 6 months of Screening) with biological immunomodulators such as tumor necrosis factor-alpha (TNF-a) inhibitors (eg, infliximab, adalimumab).
- •4. Current evidence of clinically significant cardiovascular, neurological, hepatic, renal, hematological, lymphatic, metabolic, or gastrointestinal disease, or has a condition that requires other treatment, may not allow safe participation, or which in the opinion of the Investigator should preclude the patient’s participation in the clinical study.
- •5. Clinically significant pulmonary hypertension requiring vasodilator treatment.
- •6. Any history of tuberculosis or evidence of active systemic non-tuberculous fungal or mycobacterial infection within 1 year of Screening.
- •7. History of clinically significant cardiac, neurological, gastrointestinal, and/or renal manifestations of their sarcoidosis.
- •8. Any history of malignancy.
- •9. Major surgery within 3 months prior to Day 1 or anticipated surgery during the study.
- •10. Any condition that necessitated hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
- •11. Participation in another clinical study of an investigational agent or device within 3 months (small molecules) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
- •12. History of or positive results of screening for hepatitis B (hepatitis B surface antigen [HBsAg]), hepatitis C (anti-hepatitis C virus [HCV] antibodies [Ab]) or human immunodeficiency virus (HIV) (HIV Ab type 1 and 2).
- •13. Has been an active smoker (including e-cigarettes or e-vaporizers) within 3 months prior to Screening.
- •14. Active substance abuse (drugs or alcohol) or history of substance abuse within the 12 months prior to Screening.
- •15. Clinically significant abnormalities in the Screening physical examination, vital signs, ECG, or clinical laboratory test results that, in the opinion of the Investigator and Medical Monitor should preclude the patient’s participation in the clinical study.
- •16. Patient has received a live vaccination within 8 weeks before Day 1 or inoculation with a live vaccine is planned during study participation.
- •17. Jo-1 Ab levels >7 U/mL at Screening, or past history of Jo-1 Ab positivity.
- •18. Any other condition or circumstance that, in the opinion of the investigator, would be likely to prevent adequate compliance with the study protocol.
- •19. Significant and/or acute illness (eg, change in pulmonary status, infection requiring antibiotics) within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
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