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

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

ClinicalTrials.gov Identifier: NCT03926611

Novartis Reference Number: CLOU064A2201

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is 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

Condition

Chronic Spontaneous Urticaria

Phase

Phase 2

Overall status

Recruiting

Enrollment count

308 participants

Last update

Aug 12, 2020

Start date

Jun 06, 2019

Completion date

Apr 22, 2021

Gender

All

Age(s)

18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug

LOU064 Arm 1

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

Drug

LOU064 Arm 2

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

Drug

LOU064 Arm 3

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

Drug

LOU064 Arm 4

Low dose of LOU064 orally, twice daily from Day 1 to 85

Drug

LOU064 Arm 5

Medium dose of LOU064 orally, twice daily from Day 1 to 85

Drug

LOU064 Arm 6

High dose of LOU064 orally, twice daily from Day 1 to 85

Drug

Placebo arm

Matching placebo, orally, twice daily from Day 1 to 85

Eligibility Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.