EUCTR2021-005947-58-ES进行中（未招募）1 期
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients with Active Psoriatic Arthritis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Participant is =18 years of age;
- •2. Participant has a confirmed diagnosis of PsA per the 2006 ClASsification criteria for Psoriatic ARthritis (CASPAR) with symptoms for =6 months prior to the Screening Visit;
- •3. Participant has active disease (defined by a TJC68 of =3 and a SJC66 of =3);
- •4. Participant has either current active PsO or a history of PsO; in either case, this diagnosis must have been confirmed by a dermatologist;
- •5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
- •6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
- •7. Participant must be, in the opinion of the investigator at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information. If a chest X-ray or computer tomography (CT) scan for tuberculosis (TB) screening is required per local guidance, the X-ray or CT scan must be taken within 3 months prior to the Screening Visit;
- •8. Participant has had an inadequate response at the Screening Visit (lack of efficacy after =12-week duration of therapy) to previous or current treatment with =1 non-biologic disease-modifying anti-rheumatic drug (DMARD) at maximally tolerated dose, or participant has an intolerance to or contraindication for DMARDs as defined by the investigator;
- •9. If the participant is female, she must be of non-childbearing potential or – if of childbearing potential, participant must agree to use highly effective methods of contraception.
- •10. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit and a negative urine pregnancy test at Week 0/Day 1 prior to the first administration of study treatment;
- •11. If male, participant must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for 12 weeks after the last dose of study treatment, unless surgically sterile;
- •12. Participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator;
- •13. Participant is able to understand and provide signed informed consent.
- •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 20
排除标准
- •1. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients;
- •2. Subjects who currently uses or plans to use 1 or more prohibited treatments specified in this protocol. Prohibited treatments and washout periods detailed in the protocol must be adhered to;
- •3. Subjects who has previously failed on anti (IL)-17 therapy, after at least 16 weeks of treatment; or is unsuitable for anti-IL-17 therapy for any reason according to the investigator’s discretion;
- •4. Subjects who has previously failed on anti-tumor necrosis factor alpha (TNFa) therapy, after at least 16 weeks of treatment; or is unsuitable for anti-TNFa therapy for any other reason according to the investigator’s discretion;
- •5. Subjects who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit, including but not limited to IL-17 inhibitors, IL-23 inhibitors, TNFa inhibitors, etc;
- •6. Subjects who has a diagnosis of chronic inflammatory conditions other than PsO or PsA, including but not limited to rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, Crohn’s disease, or ulcerative colitis;
- •7. Has a diagnosis of arthritis mutilans;
- •8. Has an active infection or history of infections, as defined in the protocol;
- •9. Subjects who received a live (including attenuated) vaccination within 8 weeks before study treatment initiation, or planned to receive a live vaccination during the study and up to at least 12 weeks after the last dose of study treatment. Examples of restricted vaccinations provided in the protocol;
- •10. Subjects who received a Bacillus Calmette-Guérin (BCG) vaccination within 1 year before study treatment initiation;
- •11. Participant with:
- •a. A history of active tuberculosis (TB).
- •b. Evidence of TB infection, unless the criteria as defined by the protocol apply.
- •12. Any current nontuberculous mycobacterial (NTM) infection or any history of pulmonary NTM infection at the Screening Visit;
- •13. Evidence of acute ocular inflammation, including active anterior uveitis (i.e., acute episode), within the last 4 weeks before study treatment initiation;
- •14. Concurrent malignancy or a history of malignancy during the past 5 years of the Screening Visit, exceptions providing in the protocol;
- •15. Subjects with fibromyalgia, osteoarthritis symptoms, or any other condition that in the investigator’s opinion may potentially interfere with efficacy assessments;
- •16. Subjects with erythrodermic, guttate, or pustular form of PsO or drug-induced PsO;
- •17. History of a lymphoproliferative disorders, including lymphoma, or current signs and symptoms suggestive of lymphoproliferative disease;
- •18. Primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants;
- •19. Had major surgery (including joint surgery) within 6 months, or is planning to have major surgery during the study;
- •20. Presence of active suicidal ideation, or positive suicidal behaviour, shows any history of suicidal attempt (including an actual attempt, interrupted attempt, or aborted attempt), or suicidal ideation in the past 6 months;
- •21. Subjects has presence of moderately severe depression or severe depression, indicated by a score of =15 using the screening PHQ-9. Subjects are permitted to use 1 medication to treat depression provided dose is stable for 4 weeks prior to initiation of study treatment. Subjects on multiple medications for depression ar
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