Rheumatoid Arthritis
Conditions
Interventions
ELV001
Placebo
Sponsors
Elevara Medicines Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, a participant must meet all of the following inclusion criteria: 5. Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol. 6. Male or female, 18 to 75 years of age, at the time of signing the informed consent. 7. Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit. 8. Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening. 9. Have active RA defined by a DAS28-CRP = 3.2 and the presence of =3 swollen joints (based on 66 joint count) and =3 tender joints (based on 68 joint count) at Screening and Baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. 10. Have C-reactive protein (CRP) = upper limit of normal (ULN) at Screening. 11. Have adequate hematologic function at Screening AND at Baseline as defined below (repeat measurement of borderline values permitted): • absolute neutrophil count =2.5 × 109/L (=2.5 × 103/µL or =2.5 GI/L), • platelet count =100 × 109/L (=100 × 103/µL or =100 GI/L), • hemoglobin level =10.0 g/dL, • lymphocyte count >500 cells/µL (>0.50 × 103/µL or >0.50 GI/L), • total leukocyte count =3.0 × 109/L (=3.0 × 103/µL or =3.0 GI/L). 12. Have adequate liver and renal function at Screening as defined below (repeat measurement of borderline values permitted): • serum creatinine, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels =2 × ULN • total bilirubin level (TBL) and alkaline phosphatase (ALP) =1.5 × ULN • estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 (calculated by site laboratory or using the CKD-EPI [Chronic Kidney Disease Epidemiology Collaboration] formula). 13. Are currently treated with MTX (methotrexate) with folic acid
Exclusion criteria
Exclusion criteria: A participant who meets any of the following exclusion criteria must be excluded from the study: 18. Class IV RA according to ACR revised response criteria. 19. Have been treated with 1 previous bDMARDs or tsDMARDs, excluding the current TNFi. 20. Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator. 21. Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline. 22. Have oral prednisone >7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline. 23. Have intra-articular corticosteroids within the last 4 weeks before Baseline. 24. Had any other csDMARD, bDMARD, or immunosuppressive drug in the last 8 weeks. 25. Had any cell depletion therapy (eg, rituximab) in the last 12 months 26. Have QT interval corrected for heart rate (QTc) using Fridericia’s correction (QTcF) > 450 ms for males or QTcF > 470 ms for females either at Screening or Baseline, based on safety 12-lead electrocardiogram (ECG). Have a Screening or Baseline ECG with second- or third-degree atrioventricular block, bundle branch block, arrhythmia (but not sinus arrhythmia or supraventricular premature beats), or illegible QT interval. 27. Have evidence of ILD based on either medical history, clinical signs and symptoms, imaging and/or lung function test, independently of the etiology of the ILD. 28. Have a condition which could interfere with drug absorption including but not limited to short bowel syndrome. 29. Have presence of 1 or more significant concurrent medical conditions, which could interfere with the treatment and/or the study per Investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of ELV001 as an add-on treatment to standard-of-care in participants with active RA. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the safety and tolerability of ELV001 as an add-on treatment to standard-of-care in participants with active RA;To examine the impact of ELV001 on disease activity as an add-on treatment to standard-of-care in participants with active RA.;To evaluate the plasma PK of ELV001 in participants with active RA. | — |
Countries
South Africa
Contacts
Public ContactCaroline Sibeko
Senior Clinical Operations Manager
Outcome results
None listed