EUCTR2016-003936-19-HU进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
SUN Pharmaceuticals Global FZE0 个研究点目标入组 180 人开始时间: 2017年1月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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. Subject has provided informed consent.
- •2. Subject is = 18 years of age at time of Screening.
- •3. Definite AS based on the modified New York criteria (1984) with symptom duration of at least 3 months at Screening as defined by modified New York criteria (1984), or for nr-axSpA, a documented diagnosis of adult onset axial spondyloarthritis as defined by the specific ASAS criteria with at least 3 months symptom duration before Screening.
- •4. Subjects with nr-axSpA must have active inflammation (MRI) on Screening and no radiographic sacroiliitis that fulfils the 1984 modified New York criteria.
- •5. Active disease at Screening, defined as:
- •- BASDAI score (0-10) of at least 4, and
- •- Response to the BASDAI question of ‘How would you describe the overall level of AS neck, back or hip pain you have had?’ of 40 or more on the VAS (0-100 mm), despite maximum tolerated doses of nonsteroidal anti-inflammatory drugs (NSAIDs).
- •6. Have either an inadequate response for axial symptoms to 30 days of optimal daily doses of at least 1 NSAID or intolerance to at least 2 NSAIDs as defined to include indigestion, heartburn, dizziness, headache, nausea, vomiting, constipation, diarrhea, decreased appetite, and/or rash.
- •7. The following concomitant medications are allowed if the dosage remained stable for at least 4 weeks before the Baseline visit and during the study:
- •- sulfasalazine (up to 3 g a day), in subjects who have been treated for at least 3 months prior to Baseline,
- •- methotrexate (MTX) (up to 25 mg per week) with no change in route of administration and only in subjects who have been treated for at least 3 months prior to Baseline,
- •- prednisone or prednisone equivalent (up to 10 mg per day).
- •Tapering of any of these concomitant medications during the study is allowed only if there is toxicity (accompanied by recording of an AE on the electronic case report form [eCRF]); otherwise the dosage must remain the same throughout Part 1 of the study. Adjustment of concomitant medication is permitted throughout Part 2 (Week 25 to 52) as needed (PRN) per Investigator discretion and therapeutic needs of the subject.
- •8. For subjects receiving NSAIDs (including PRN use): the subject must be on a stable dose for = 2 weeks prior to initiation of IMP and be expected to maintain a stable dose for the first 24 weeks of the study, unless change in dosage is required due to toxicity.
- •9. Subject has a negative test for tuberculosis (TB) within 4 weeks before initiating IMP, defined as:
- •- a negative QuantiFERON® test,
- •- AND a posterior-anterior and lateral chest radiogram performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases).
- •10. Subjects with a positive or 2 successive indeterminate QuantiFERON tests are allowed if they have all of the following:
- •- no history of active TB or symptoms of TB,
- •- if prior latent TB infection, the subject must have a history of adequate prophylaxis (per local standard of care),
- •- if presence of latent TB is established, then treatment according to local country guidelines must have been followed for at least 4 weeks prior to inclusion in the study.
排除标准
- •1. Radiographic evidence of total ankylosis of the spine (defined by syndesmophytes present on the lateral views of spinal radiographs at all intervertebral levels from T6 through S1; films will be read centrally).
- •2. Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes.
- •3. Active uveitis or symptomatic inflammatory bowel disease requiring therapy at Screening.
- •4. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition.
- •5. Subject has an active infection or history of infections as follows:
- •- any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,
- •- any serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first investigational product dose, with the last dose having been received within 7 days of Screening,
- •- recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
- •6. Major chronic inflammatory or connective tissue disease other than AS (e.g., psoriatic arthritis [PsA], rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, and gout).
- •7. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause this study to be detrimental to the subject.
- •8. Subject has known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- •9. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
- •10. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- •11. Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
- •12. Subjects with a history of alcohol or drug abuse in the previous 2 years.
- •Laboratory abnormalities
- •13. Subject has laboratory abnormalities at Screening, including any of the following:
- •- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 times the upper limit of normal (ULN),
- •- creatinine = 1.5 times ULN,
- •- serum direct bilirubin = 1.5 mg/dL,
- •- white blood cell (WBC) count < 3.0 x 103/µL,
- •- any other laboratory abnormality that, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
- •Washouts and non-permitted drugs
- •14. Disease modifying anti-rheumatic drugs (DMARD) other than NSAIDs, MTX or sulfasalazine must be discontinued 4 weeks prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomi
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Safety and Effectiveness of ADX-914 in Subjects with Moderate to Severe Atopic DermatitisModerate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785CTIS2023-510238-10-00Q32 Bio Inc.102
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).MedDRA version: 20.0Level: PTClassification code 10077827Term: C3 glomerulopathySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2017-001821-42-ESChemoCentryx, Inc.44
进行中（未招募）
1 期
Effectiveness and safety of riociguat in patients with sclerosis of the skidiffuse cutaneous systemic sclerosis (dcSSc)MedDRA version: 18.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859EUCTR2014-001353-16-BEBayer HealthCare AG130
进行中（未招募）
不适用
The study is designed to determine the safety and efficacy of progesterone in patients with severe head injurySevere traumatic brain injuryMedDRA version: 16.0Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863EUCTR2010-018283-16-NLBHR Pharma, LLC1,180
进行中（未招募）
1 期
A study evaluating safety and efficacy of Itacitinib or Placebo in combination with corticosteroids for the treatment of first-line acute graft versus-host diseaseMale or female, 18 years of age or older who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT) and have developed Grade II to IV acute GVHDMedDRA version: 20.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066262Term: Acute graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066263Term: Acute graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disordersEUCTR2017-000538-78-GBIncyte Corporation436