2025-521503-43-00招募中2 期
A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- IGA response at week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
研究概览
简要总结
To assess the efficacy of GIA632 compared to placebo at Week 16
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females, who are ≥ 18 years of age at the time of the initial screening visit
- •Diagnosis of atopic dermatitis (according to the Hanifin and Rajka (1980) criteria) and onset of disease for at least 1 year prior to screening visit
- •Moderate to severe atopic dermatitis as defined by all of the following (baseline assessments are performed on Day 1 prior to treatment): IGA score ≥ 3 at the screening and the baseline visit;
排除标准
- •Participants taking prohibited medication/therapy not completing the wash-out period as specified in prohibited medication section Table 6-5 of the protocol
- •Regular use (≥ 2 visits per week) of a tanning booth/parlor or extended sun exposure (per Investigator judgement) within 4 weeks of the baseline visit
- •Meet any of the following infection criteria: • Active chronic or acute infection requiring systemic treatment within 14 days before the baseline visit or a superficial skin or mucocutaneous infection (e.g. unresolved tinea corporis or herpes labialis; but not including fungal nail infection) within 7 days before the baseline visit; Note: Participants may be re-screened after infection resolves • Acute or chronic infection with hepatitis B (HBV) as tested at screening. Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant. HBsAg negative participants who are hepatitis B core antibody (HBcAb) positive are also excluded, unless: i) Hepatitis B Deoxyribonucleic acid (HBV DNA) is negative, and ii) Hepatitis B reactivation monitoring is implemented (HBsAg and HBV DNA tested on a monthly basis while on study treatment, and at least every 12 weeks thereafter for the entire duration of study follow-up) (refer to Section 8.1.2.1). • Acute or chronic hepatitis C (HCV) as tested at screening. Participants with a positive HCV antibody test should have HCV ribonucleic acid (RNA) levels measured. Participants with positive (detectable) HCV RNA must be excluded. Chronic hepatitis C patients who have completed HCV anti-viral treatment must be HCV-RNA negative for at least 12 weeks after treatment before randomization to be eligible (these patients may be Hep C antibody positive). Cases of spontaneous HCV clearance should be discussed with the Sponsor before enrollment and are subject to approval by a hepatologist or an infectious diseases specialist prior to enrollment. • History of human immunodeficiency virus (HIV) infection or positive HIV test at screening • Known or suspected history of immunosuppression or immune deficiency including a history of invasive opportunistic infections (e.g. histoplasmosis, listeriosis, pneumocystosis, aspergillosis) or unusually frequent, recurrent or prolonged infections per the Investigator’s judgement.
- •Any clinically significant abnormal findings in the clinical laboratory tests, vital signs and/or physical examination during the screening period, which in the opinion of the investigator, may put the participant at risk because of their participation in the trial, or may influence the results of the trial, or the participant’s ability to complete the entire duration of the trial.
- •History or current diagnosis of electrocardiogram (ECG) or cardiac abnormalities indicating significant risk of safety for participants, including clinically significant abnormalities on the screening 12-lead electrocardiogram (ECG at the screening visit and/or baseline visit), as judged by the investigator.
- •Participant with any other active inflammatory skin disease other than atopic dermatitis (e.g. psoriasis) requiring systemic or topical treatment within 28 days prior to the baseline visit or would interfere with the appropriate assessment of atopic dermatitis in the opinion of the investigator
- •Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per judgment of the investigator
- •Any clinically unstable disease states that would likely require rescue systemic corticosteroids (e.g., severe and/or uncontrolled asthma) that may interfere with data interpretation.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for CCI after stopping study treatment. Women are considered postmenopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). For details regarding highly effective contraception method, refer to Section 5.2.
结局指标
主要结局
IGA response at week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
IGA response at week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
次要结局
- Treatment-emergent adverse events (TEAEs) until End of Study (EoS)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (6)
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