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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo arm; Drug: LOU064 Arm 5; Drug: LOU064 Arm 1; Drug: LOU064 Arm 6; Drug: LOU064 Arm 4; Drug: LOU064 Arm 3; Drug: LOU064 Arm 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926611

2018-000993-31 (EudraCT Number)

CLOU064A2201

Details and patient eligibility

About

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

Full description

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.

Enrollment: 311 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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311 participants in 7 patient groups, including a placebo group

LOU064 Arm 1

Experimental group

Description:

10 mg LOU064 qd capsule once daily

Treatment:

Drug: LOU064 Arm 1

LOU064 Arm 2

Experimental group

Description:

35 mg capsule qd LOU064 once daily

Treatment:

Drug: LOU064 Arm 2

LOU064 Arm 3

Experimental group

Description:

100 mg capsule qd LOU064 once daily

Treatment:

Drug: LOU064 Arm 3

LOU064 Arm 4

Experimental group

Description:

10 mg capsule LOU064 bid

Treatment:

Drug: LOU064 Arm 4

LOU064 Arm 5

Experimental group

Description:

25 mg capsule LOU064 bid

Treatment:

Drug: LOU064 Arm 5

LOU064 Arm 6

Experimental group

Description:

100 mg capsule LOU064 bid

Treatment:

Drug: LOU064 Arm 6

Placebo Arm

Placebo Comparator group

Description:

Participants took matching placebo twice daily

Treatment:

Drug: Placebo arm