A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis

Официальное название

An Open-label, Parallel Group, Multicenter Study Evaluating the Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants With Moderate to Severe Plaque Psoriasis

Обзор

The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis.

Подробное описание

The study consists of Screening Phase (4 weeks before administration of study drug), Active Treatment Phase (Week 0-Week 86), Follow-up Phase (Week 86-Week 98). During various study periods, safety assessments (example \[e.g\] recording of adverse events, Vital signs, Tuberculosis evaluation, Chest radiograph, Urine pregnancy test); Efficacy assessments (e.g PASI, IGA, ss-IGA, NAPSI, DLQI); Clinical laboratory assessments (e.g hematology, chemistry); Biomarkers/Genetic evaluations, will be performed per the study procedures. The primary hypotheses are that guselkumab treatment with high-dose and extended-interval is non-inferior to standard dose as assessed by proportion of participants achieving PASI 90 and IGA 0/1 response at Week 86 with noninferiority margin of 13%.

Вмешательства

• Препарат Guselkumab
  Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.
• Препарат Guselkumab
  Participants will receive 1 injection of active guselkumab (100 mg, SC) at Weeks 0, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76 and 84.

Первичные конечные точки

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86 [Срок оценки: Week 86]
• Percentage of Participants Who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 86 [Срок оценки: Week 86]
• Number of Participants with Adverse Events (AE) [Срок оценки: Up to Week 98]
• Number of Participants with Change from Baseline in Laboratory Abnormalities [Срок оценки: Up to Week 98]
• Number of Participants with Abnormalities of Electrocardiogram (ECG) [Срок оценки: Up to Week 98]
• Number of Participants with Change from Baseline in Vital Signs [Срок оценки: Up to Week 98]
• Number of Participants with Change from Baseline in Physical Examination [Срок оценки: Up to Week 98]
• Number of Participants with Change from Baseline in Concomitant Medications [Срок оценки: Up to Week 98]
• Number of Patients with Injection-site Reactions [Срок оценки: Up to Week 98]
• Number of Patients with Allergic Reactions [Срок оценки: Up to Week 98]

Вторичные конечные точки (12)

• Percentages participants who Achieve a PASI 100, PASI 75, and PASI 50 Response at Week 86 and Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Percentage of Participants who Achieve a PASI 90 Response Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Percentage of Participants who Maintain PASI 90 Responders at Week 86 Among Participants who were PASI 90 Responders at Week 48 [Срок оценки: Week 86]
• Percentage of Participants who Maintain IGA Score of Cleared (0) or Minimal (1) at Week 86 Among Participants who Achieved IGA 0/1 at Week 48 [Срок оценки: Week 86]
• Percentage of Participants who Achieve an IGA Score of Cleared (0) and an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 86 and Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1 [Срок оценки: Week 12, 20, 52 and 86]
• Percentage of Participants with a Reduction of 5 or More Points in DLQI Score Over Time [Срок оценки: Week 12, 20, 52 and 86]
• Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 36 and Over Time Among Participants with Nail Psoriasis at Baseline [Срок оценки: Week 12, 20, 36, 52 and 86]
• Percentage of Participants with a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) Over Time Among Participants with Scalp Psoriasis and an ss-IGA Score >=2 at Baseline [Срок оценки: Week 12, 20, 36, 52 and 86]
• Percentage of Participants who Maintain PASI value ≤0.9 at Week 52 Among Participants who had achieved at Week 20 [Срок оценки: Week 12, 20, 52 and 86]

Критерии участия

Критерии включения

• Has a diagnosis of plaque-type psoriasis (with or without \[Psoriatic Arthritis\] PsA) for at least 6 months before the first administration of study drug.
• Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >=3, or Investigator's Global Assessment (IGA) >=3, or Affected Body Surface Area (BSA) >= 10% at baseline (Week 0).
• Be suitable for receiving systemic treatment of psoriasis, as whether biologic-naïve or biologic-experienced participant.
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections.
• Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination.
• Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug.
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug.
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Критерии исключения

• Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular).
• Currently has drug-induced psoriasis (e.g., newly developed psoriasis or exacerbation of psoriasis due to treatment with β-blockers, calcium channel blockers, or lithium).
• Has a history of or current signs or symptoms of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter/minute \[mL/min\]); significant, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
• Currently has a or has a history of malignancy within 5 years before screening (exceptions are nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration and cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before screening, or malignancy, which is considered cured with minimal risk of recurrence).
• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
• Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, recurrent sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infection (example, recurrent pyelonephritis, recurrent cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers.
• Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07532486 · 2024-0032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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