EUCTR2021-000859-39-DK进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients with Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- 性别
- All
入选标准
- •1. Males or females, aged =40 years.
- •2. Body mass index (BMI) =40.0 kg/m2.
- •3. Diagnosis of primary OA of the Index knee (as per American College of Rheumatology (ACR) clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.
- •4. Index knee OA severity Grade 2 or 3 (based on Kellgren-Lawrence Grading Scale).
- •X-rays will be reviewed by a central reader. If a suitable x-ray performed within 6 months of the Screening Visit cannot be provided, an x-ray must be performed as part of the Screening assessments.
- •5. Subject has experienced unsatisfactory pain control from at least 2 prior standard OA treatments, or has used such medications before but chose to discontinue them due to intolerance or personal preference.
- •Standard pharmacological OA treatments include (but are not limited to): Topical or oral NSAIDs, topical capsaicin, IA corticosteroids, IA hyaluronic acid, acetaminophen / paracetamol, duloxetine, tricyclic antidepressants for treatment of pain, tramadol and other opioids.
- •Subjects considered by the Investigator to be non-responsive to treatment with corticosteroids are not eligible.
- •6. At Screening Visit 1a, subject reports that their typical OA knee pain in one or both knees when not using medication is =4 out of 10.
- •7. The weekly WOMAC Pain subscale scores for the Index knee (collected at the end of each week of the Washout and Baseline Period) are both =5.0 and =9.0 and must not differ (vary) by more than 3 points.
- •8. Demonstrated ability to comply with pain recording requirements during the Washout and Baseline Period (i.e., Subject must record daily NPRS scores (of any value) on at least 5 days in each week for both knees and both weekly WOMAC scores in both knees).
- •9. The weekly WOMAC Pain subscale scores for the non-Index knee (collected at the end of each week of the Washout and Baseline Period) are both =6.0.
- •10. Patient is ambulatory (without the need for a cane/other walking aide).
- •11. For females of child-bearing potential, willing to use a highly effective method of birth control between Baseline and End-of-Study Visits.
- •12. Willing and able to provide informed consent and comply with all study procedures and restrictions and the required visit schedule, etc.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.OA of Index knee due to acute injury or trauma that occurred within 12 months prior to Screening, or unstable joint within 12 months of Screening
- •2.X-ray evidence of chondrocalcinosis likely to affect outcome of study in opinion of inv.
- •3.Diagnosed or suspected IPSI hip OA
- •4.Knee pain not clin. attributable to OA of knee
- •5.Any other disorders that, in Inv. opinion, impact mobility, strength or sensation, or a co-existent source of pain or inflamm. that interferes with subj ability to assess knee OA pain and function
- •6.Presence of other sympt. or cond. in Index knee
- •7.History of infec. in Index knee, or clin. signs and sympt. of active infec.
- •8.Total/partial KR or other surgery of Index knee
- •10.IA injection of CSs in any joint within 3 months prior to Screening, or IA injection of ext-release CSs in any joint
- •12.P.o., i.v. or i.m. CSs for any indication within 30 days prior to Baseline; or planned used during study
- •13.Inh or In CSc, from start of Washout and Baseline Period until at least 4 Weeks post-dose
- •14.Any tp CSs applied to Index knee
- •15.Use of long-acting opioids within 30 days prior to Screening, or use of any opioids more than twice per week within 30 days prior to Screening and from which subj. is unwilling or unable to washout
- •18.Presence of alcoh. abuse or dependence
- •19.Current use of systemic ISx therapy; or use within 6 months prior to Screening
- •20.Unwilling or unable to washout of any prohibited meds
- •21.Use of another IMP or device within 30 days prior to Screening, or investigational biologic within 60 days prior to Screening, or current/planned participation in other interventional trial during study
- •22.History of sarcoidosis or amyloidosis
- •23.History of osteomyelitis
- •24.History of or active Cushing’s
- •25.Currently receiving treatment for following conditions: psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders. Mild or well-controlled psych. disorders are permitted if the medication used is not prohibited by protocol
- •26.At Screening, a baseline serum cortisol value =138 nmol/L (<5 µg/dL) from the ACTH stimulation test or an abnormal ACTH stimulation test result
- •27.Currently has diagn. insulin depend. diabetes mellit. or poorly control. non-insulin dependent diabetes mellit. at Screening.
- •Pre-diabetics and well-controlled, non-insulin depend. diabetics are permitted.
- •28.Diagnosed hepatic or renal disease
- •29.Current malignancy of any type, or history of malignancy within 12 month prior to Screening
- •30.Any infec. requiring IV antibiotics within 4 weeks of the Baseline Visit, or oral ABX within 2 weeks of the Baseline Visit
- •31.Known active or quiescent systemic fungal, bacterial viral or parasitic infec., or ocular herpes simplex
- •32.Known or clinically suspected infec. with HIV, hepatitis B or C viruses
- •33.Skin breakdown on Index knee
- •34.Females who are pregnant, lactating, or who have positive pregnancy test at Screening or Baseline Visits
- •35.Known or suspected hypersensitivity or contraindication to any ingredients in IMP, to FP or any other corticosteroids, or lidocaine.
- •37.Previous RND and TRT in this study
- •38.Any other reason that, in opinion of INV, is likely to unfavorably alter subject risk-benefit, confound safety or efficacy results, or make it difficult for the subject to fully comply with study requirem.
- •Additional ex criteria for the optional MRI Sub-Study
- •Subj. who are willing to participate in imaging sub-study are also subject to following ex criteria. If a subject meets
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