This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Novartis Pharmaceuticals311 enrolled

Overview

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

311

Conditions

Chronic Spontaneous Urticaria

Interventions

LOU064 Arm 1DRUG

10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

LOU064 Arm 2DRUG

35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

LOU064 Arm 3DRUG

100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects aged ≥18 years of age * CSU diagnosis for ≥ 6 months prior to screening * Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period * UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1) * Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study Exclusion Criteria: * Hypersensitivity to any of the study treatments * Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) * Other diseases with symptoms of urticaria or angioedema * Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, * Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C. * Pregnant or nursing (lactating) women * Women of child-bearing potential not using highly effective methods of contraception

Locations (82)

Outcomes

Primary Outcomes

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4

UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Time frame: Baseline, Week 4

Secondary Outcomes

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)

Time frame: Week 12

Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)

UAS7=0 and UAS7\<=6 response rate over time by treatment group (non-responder imputation) The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates more severe disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Time frame: Week 12

Cumulative Number of Weeks With an AAS7=0 Response

The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reports the occurrence of angioedema ("opening question") with "no", AAS score for this day is 0. If "yes" is the answer to the opening question, the subject will continue to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105. Higher score means more severe disease.

Data from ClinicalTrials.gov

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Novartis Investigative Site

Litchfield Park, Arizona, United States

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Little Rock, Arkansas, United States

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Mission Viejo, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Westminster, California, United States

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Pembroke Pines, Florida, United States

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Owensboro, Kentucky, United States

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Ypsilanti, Michigan, United States

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St Louis, Missouri, United States

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