EUCTR2022-003056-14-HU进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients with Active Psoriatic Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
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
- •1. Men or women, aged 18 to 75 years, inclusive, at the time of consent.
- •2. Body mass index within the range of 18 to 40 kg/m2, inclusive, and total body weight > 50 kg (110 lb).
- •3. Capable of giving signed informed consent.
- •4. Diagnosed with PsA for = 6 months before Screening, and who meet the CASPAR at Screening.
- •5. Must be negative for rheumatoid factor and anti-CCP antibodies.
- •6. Must have a documented history or active signs of at least one of the following at Screening:
- •a. At least 1 confirmed lesion of plaque psoriasis of at least 2 cm,
- •b. Nail changes attributed to psoriasis.
- •7. Active PsA as defined by = 3 swollen joints (SJC66) and = 3 tender joints (TJC68) at Screening and Day 1; these need not be the same joints at Screening and Day 1.
- •8. Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following therapies:
- •a. Conventional nonbiologic DMARDs (eg, methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine), or apremilast,
- •c. Corticosteroids.
- •9. Participant either (i) did not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNFi or 1 IL-17 inhibitor. Failure is defined as lack of response or loss of response with = 12 weeks of therapy with an approved dose of a TNFi or IL-17 inhibitor, as judged by the investigator. Failure must have occurred = 8 weeks prior to Day 1 for TNFi and = 12 weeks prior to Day 1 for an IL-17 inhibitors.
- •10. Participants are permitted to receive the following medications if doses and frequency are stable for = 2 weeks prior to Day 1 and they agree to continue using them at the same dosage during the study:
- •a. NSAIDs if dose is consistent with labeling recommendations for pain,
- •b. Acetaminophen (= 4 g/day)/paracetamol,
- •c. Oral corticosteroids (= 10 mg/day prednisone equivalent),
- •d. Concurrent topical therapy for plaque psoriasis.
- •11. If on a conventional nonbiologic DMARD (eg, methotrexate, sulfasalazine, hydroxychloroquine, leflunomide; excludes apremilast), participants can continue using 1 DMARD provided it has been used for = 12 weeks prior to Day 1 with a stable dose and frequency for = 4 weeks prior to Day 1, at the same dosage during the study.
- •12. Women must meet either (a) or (b) of the following criteria and men must meet criterion (c) to qualify for the study:
- •a. A woman who is not of childbearing potential must meet 1 of the following:
- •i. Postmenopausal, defined as no menses for 12 months without an alternative medical cause, and an FSH test with a result = 30 mIU/mL, confirming nonchildbearing potential.
- •ii. Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- •b. A nonpregnant woman of childbearing potential must agree to use a highly effective contraception method that can achieve a failure rate of less than 1% per year when used consistently and correctly. The highly effective contraception must be used through the duration of the study and for 30 days after the last dose of study product. The following are considered highly effective birth control methods:
- •Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal,
- •Progesterone-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted,
- •Intrauterine device,
- •Intrauterine hormone-releasing sy
排除标准
- •1.Has non-plaque psoriasis at Screening or Day 1.
- •2.Has any disorder that, in the opinion of the investigator, would interfere with the study assessments.
- •3.Has a history or evidence of active infection and/or febrile illness = 7 days prior to Day 1.
- •4.Has a history of serious infections requiring hospitalization and/or intravenous antibiotic = 12 weeks prior to Day 1, or any infection requiring oral antibiotic = 4 weeks prior to Day 1.
- •5.Has a history of chronic or recurrent infectious disease.
- •6.Has a history of infected prosthesis or has received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.
- •7.Has an active herpes simplex infection.
- •8.Has a known immune deficiency or is immunocompromised.
- •9.Has hepatitis B infection:
- •Acute or chronic hepatitis B infection, or
- •A positive result for HBV at Screening.
- •10.Has hepatitis C infection:
- •Current hepatitis C infection, or
- •A positive result for HCV at Screening.
- •11.Has current HIV infection or AIDS, or positive HIV antibody at Screening.
- •12.Has active latent TB infection at Screening. History of untreated or inadequately treated latent TB infection.
- •13.Has had previous exposure to VTX958 or any other TYK2 inhibitor in any study.
- •14.Has had prior treatment with ustekinumab, tildrakizumab, risankizumab, guselkumab, or cyclophosphamide.
- •15.Has had treatment with secukinumab, bimekizumab, and ixekizumab < 12 weeks prior to Day 1.
- •16.Has had treatment with any experimental therapy or new investigational agent = 4 weeks or 5 half-lives prior to Day 1 or is currently enrolled in an investigational study.
- •17.Has had treatment with etanercept, adalimumab, infliximab, certolizumab, or golimumab (or other TNFi) < 8 weeks prior to Day 1.
- •18.Has had prior treatment with lymphocyte-depleting therapies, or agents that modulate B- or T-cells.
- •19.Has received any live or live-attenuated vaccine within 4 weeks prior to Day 1 or plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives, whichever is longer, after the last dose of study drug.
- •20.Has had prior treatment with any approved or investigational JAK inhibitors.
- •21.Has received systemic psoriasis medications other than biologics and/or any systemic immunosuppressants therapy = 4 weeks prior to Day 1.
- •22.Has received phototherapy = 4 weeks prior to Day 1.
- •23.Has used topical medications/treatments that could affect psoriasis evaluation = 2 weeks prior to Day 1.
- •24.Has used shampoos that contain corticosteroids, coal, tar, or vitamin D3 analogs = 2 weeks prior to Day 1.
- •25.Has used any high potency opioid analgesic at average daily doses of > 30 mg/day of oral morphine or its equivalent or use of variable doses of any opiate analgesic = 6 weeks prior to Day 1.
- •26.Is pregnant, lactating, or has a positive serum ß-hCG measured during Screening.
- •27.Has had any major surgery = 8 weeks prior to Day 1, or any planned surgery during the study.
- •28.Has any clinically significant medical condition in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- •29.Has unstable cardiovascular disease, defined as a recent clinical deterioration, or a cardiac hospitalization = 3 months prior to Screening.
- •30.Has uncontrolled arterial hypertension.
- •31.Has Class III or IV congestive heart failure by NYHA criteria.
- •32.Has been hospitalized in the past 3 months for asthma,
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