2024-516355-41-00尚未招募2 期
A 12-week randomized, participant and investigator blinded, placebo-controlled, exploratory study in adult participants with Chronic Urticaria to assess the efficacy and safety and explore the Mechanism of Action of remibrutinib (LOU064)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 16
- 主要终点
- Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6
研究概览
简要总结
CINDU cohorts: To investigate the efficacy of remibrutinib versus placebo for the most bothersome symptom in CINDU patients All cohorts: To investigate the impact of remibrutinib versus placebo on urticaria symptom control
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
- •CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization The following response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1): • Symptomatic dermographism: A Total Fric Score of ≥3 using the FricTest® 4.
- •Cold urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.
- •Cholinergic urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test after the provocation test. • Heat urticaria: Documented emergence of urticaria symptoms following heat exposure • Solar urticaria: Documented emergence of urticaria symptoms following sunlight exposure and UVA/B or light exposure/phototesting record from source records • Delayed pressure urticaria: symptoms of urticaria as diagnosed by pressure provocation with dermographometer or local application of weight on the lesional skin area (symptoms should be observed 4h to 6h after the trigger) and can be documented by the participant when outpatient. • Aquagenic urticaria: Evidence of urticaria (in patient records) after local exposure to water (e.g. wet blanket or other suitable testing approach). • Contact urticaria: Evidence of urticaria following contact to identified material causing urticaria symptoms.
- •CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
- •CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022a) not adequately controlled with H1‑AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization • CSU for ≥ 6 months
- •Participants must be willing and able to attend the protocol defined test procedure throughout the study
排除标准
- •Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study
- •Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: • urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), • food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant • hereditary or acquired angioedema.
- •CINDU patients only: To prevent a confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and shoud not have a signficant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.
- •CSU patients only: Patients should have no relevant inducible urticaria trigger
- •Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.
- •Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection
- •Pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6
Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6
Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6
Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6
次要结局
- Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12
- Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12
- Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline.
- Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (16)
Loading locations...
相似试验
已完成
3 期
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 AntihistaminesChronic Spontaneous UrticariaNCT05030311Novartis Pharmaceuticals470
进行中（未招募）
3 期
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)Hidradenitis SuppurativaNCT06799000Novartis Pharmaceuticals588
进行中（未招募）
3 期
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06840392Novartis Pharmaceuticals565
招募中
3 期
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisNCT06744920Novartis Pharmaceuticals180
招募中
2 期
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic UrticariaNCT06865651Novartis Pharmaceuticals44