EUCTR2020-005496-13-PL进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy and Safety of MBS2320 With Background Methotrexate (MTX) in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Each participant must meet all the following criteria to be enrolled in this study:
- •1.Between 18 and 75 years of age, inclusive.
- •2.Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/EULAR criteria for =3 months prior to screening.
- •3.Has active RA as defined by the following minimum disease activity criteria:
- •o=6 swollen joints (based on 66 joint counts) at screening and baseline visits.
- •o=6 tender joints (based on 68 joint counts) at screening and baseline visits.
- •ohsCRP > upper limit of normal reference range (ULN) at screening. On repeat assessment is acceptable for C-reactive protein per Investigator's discretion if all other eligability criteria are met.
- •4.Considered to be inadequately responding to oral or parenteral MTX therapy for =3 months and <10 years prior to screening and to be tolerating a dose of 15 to 25 mg per week for at least 56 days prior to baseline visit. Participants should also be on a stable dose of folic acid (or equivalent) for at least 56 days prior to baseline visit. Participants should continue with their stable doses of MTX and folic acid throughout the study.
- •5.Except for MTX, must have discontinued all oral DMARDs prior to baseline visit as specified below or for at least 5 half-lives of a drug, whichever is longer:
- •o=4 weeks prior to baseline visit for minocycline, D-penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, oral or parenteral gold formulations.
- •o=8 weeks prior to baseline visit for leflunomide if no elimination procedure was followed or adhere to a washout procedure (i.e. 11 days washout with cholestyramine or 30 days washout with activated charcoal) and for oral cyclosporine.
- •o=24 weeks prior to the baseline visit for cyclophosphamide.
- •6.Negative test for TB by QuantiFERON-TB Gold In-Tube test. Indeterminate results may be repeated and if negative or still indeterminate, participant may be included in the study if they have no clinical symptoms of TB, have had no known exposure to TB, and have had a negative chest X ray within previous 3 months.
- •7.If participants are taking NSAIDs or acetaminophen for stable medical conditions, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit and the doses of the medications should be kept stable throughout the study. Non-steroidal anti-inflammatory drugs, acetaminophen, tramadol, codeine, hydrocodone, and propoxyphene on a need basis, these drugs should not be taken 24 hours prior to any study visit.
- •8.If participants are taking oral corticosteroids (equivalent to prednisolone =10 mg), or inhaled corticosteroids, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions. The doses of the medications should be kept stable throughout the study. Oral and inhaled corticosteroids taken as needed are allowed but may not be taken 24 hours prior to any study visit.
- •9.Willing to provide written informed consent to participate in the study and to abide by the study restrictions.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1.Abnormality in heart rate or blood pressure at screening that increases the risk of participating in the study.
- •2.Abnormality in the 12-lead ECG at screening increases the risk of participating in the study.
- •oSpecific exclusion criteria are participants with QTcF of >450 ms (males) or >460 ms (females) and participants with PR interval of >220 ms at screening (1 repeat assessment is allowed).
- •3.Significant history of drug allergy, including to MBS2320 or excipients
- •4.Allergic reaction, anaphylaxis, or other reactions to sulphonamides drugs.
- •5.Any clinically significant neurological, GI, renal, hepatic, CV, psychiatric, respiratory, metabolic, endocrine, haematological, ophthalmic, or other major disorder which, in the opinion of the Investigator, would put the participant at risk by participating in the study (except for RA or disorders associated with RA that, in the Investigator’s opinion, do not constitute a risk when taking the IP and would not interfere with the study objectives).
- •6.Any current malignancy or a history of malignancy within 5 y prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •7.Any other inflammatory or arthritic disease in addition to RA that may interfere with the study
- •8.Active infection that is clinically significant, or requiring hospitalisation or treatment with i.v. antimicrobials =60 days of screening, or any infection requiring oral antimicrobial therapy =2 weeks of the baseline visit.
- •9.Clinical significant features of arthroses that could interfere with study assessments and objectives.
- •10.Prior exposure to any JAK inhibitor, investigational or approved
- •11.Prior exposure to any biologic RA therapy, investigational or approved, or any approved or investigational monoclonal antibody or recombinant protein therapy
- •12.Prosorba column treatment within 60 days prior to baseline visit.
- •13.Current or expected need of other immunosuppressant medications including >10 mg oral prednisolone/day or equivalent corticosteroid therapy (see Inclusion Criterion 8). Use of MTX as described in Inclusion Criteria 4 is permitted.
- •14.Any i.v, i.m., or intra-articular corticosteroids within 30 days prior to baseline visit or expected to require parenteral corticosteroid through the study.
- •15.High potency opiates
- •16.Oral bisphosphonates within 6 months prior to baseline visit or once-a-year i.v. bisphosphonates within 1 year prior to baseline visit.
- •17.Any prior use of denosumab.
- •18.Use of strong CYP3A4 inhibitors/inducers within 30 days or 5 half-lives, whichever is longer, prior to baseline visit.
- •19.Use of B7 (UGT2B7) inhibitors within 30 days or 5 half-lives, whichever is longer, prior to baseline visit.
- •20.Systemically administered CA inhibitors within 30 days or 5 half-lives, whichever is longer, prior to baseline visit.
- •21.Any prior use of cytotoxic agents for indications other than RA
- •22. Participation in another clinical study (including attending follow-up visits) or receipt of any investigational drug of chemical or biologic nature within a minimum of 90 days or 5 half-lives of the drug (whichever is longer) prior to baseline visit.
- •23.Previously received MBS2320.
- •24. Chest X-ray within 90 days prior to baseline visit that shows an abnormality suggestive of malignancy, current infection, or old inactive TB.
- •25. Screening laboratory values meeting the following criteria: o Serum AST or alanine
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