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

NCT ID: NCT03926611

Last Updated: 2022-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2021-04-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Spontaneous Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebocontrolled study investigating the efficacy, safety and tolerability of 6 dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. Study duration was 18 weeks (2 weeks of screening period; 12 weeks of treatment period and a 4 weeks follow-up period).

Study had 7 arms: 10 mg LOU064 q.d.; 35 mg LOU064 q.d.; 100 mg LOU064 q.d.; 10 mg LOU064 b.i.d.; 25 mg LOU064 b.i.d.; 100 mg LOU064 b.i.d.; and Placebo

Throughout study, subjects were treated with a 2nd generation H1-antihistamine at a locally approved licensed posology ("background medication"). Subjects could take an additional second generation H1-antihistamine that was eliminated primarily via renal excretion (e.g. cetirizine, levocetirizine or bilastine) as rescue medication. Eligible subjects could roll over to extension at Wk 12 or Wk 16
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LOU064 Arm 1

10 mg LOU064 qd capsule once daily

Group Type EXPERIMENTAL

LOU064 Arm 1

Intervention Type DRUG

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

LOU064 Arm 2

35 mg capsule qd LOU064 once daily

Group Type EXPERIMENTAL

LOU064 Arm 2

Intervention Type DRUG

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

LOU064 Arm 3

100 mg capsule qd LOU064 once daily

Group Type EXPERIMENTAL

LOU064 Arm 3

Intervention Type DRUG

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

LOU064 Arm 4

10 mg capsule LOU064 bid

Group Type EXPERIMENTAL

LOU064 Arm 4

Intervention Type DRUG

10mg bid of LOU064 orally, twice daily from Day 1 to 85

LOU064 Arm 5

25 mg capsule LOU064 bid

Group Type EXPERIMENTAL

LOU064 Arm 5

Intervention Type DRUG

25 mg bid of LOU064 orally, twice daily from Day 1 to 85

LOU064 Arm 6

100 mg capsule LOU064 bid

Group Type EXPERIMENTAL

LOU064 Arm 6

Intervention Type DRUG

100 mg bid of LOU064 orally, twice daily from Day 1 to 85

Placebo Arm

Participants took matching placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo arm

Intervention Type DRUG

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

Interventions

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LOU064 Arm 1

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

Intervention Type DRUG

LOU064 Arm 2

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

Intervention Type DRUG

LOU064 Arm 3

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

Intervention Type DRUG

LOU064 Arm 4

10mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type DRUG

LOU064 Arm 5

25 mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type DRUG

LOU064 Arm 6

100 mg bid of LOU064 orally, twice daily from Day 1 to 85

Intervention Type DRUG

Placebo arm

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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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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Grove City, Ohio, United States

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CABA, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mendoza, Mendoza Province, Argentina

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CABA, , Argentina

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Edegem, Antwerpen, Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Niagara Falls, Ontario, Canada

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Ottawa, Ontario, Canada

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Verdun, Quebec, Canada

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Québec, , Canada

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Prague, Czech Republic, Czechia

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Prague, Prague 1, Czechia

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Tábor, , Czechia

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Arhus C, , Denmark

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Copenhagen NV, , Denmark

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Lille, , France

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Nantes, , France

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Nice, , France

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Pierre-Bénite, , France

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Rouen, , France

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Berlin, , Germany

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Dresden, , Germany

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Gera, , Germany

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Hanover, , Germany

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München, , Germany

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Debrecen, Hajdú-Bihar, Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Orosháza, , Hungary

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Pécs, , Hungary

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Szolnok, , Hungary

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Ichinomiya, Aichi-ken, Japan

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Funabashi, Chiba, Japan

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Hiroshima, Hiroshima, Japan

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Obihiro, Hokkaido, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Itabashi-ku, Tokyo, Japan

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Koto, Tokyo, Japan

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Takaoka, Toyama, Japan

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Amsterdam, , Netherlands

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Utrecht, , Netherlands

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Gdansk, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Rzeszów, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Stavropol, , Russia

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Košice, Slovak Republic, Slovakia

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Nové Zámky, , Slovakia

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Svidník, , Slovakia

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Alicante, Valencia, Spain

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Madrid, , Spain

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Madrid, , Spain

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Istanbul, TUR, Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Talas / Kayseri, , Turkey (Türkiye)

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Leeds, , United Kingdom

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London, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

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Countries

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United States Argentina Belgium Canada Czechia Denmark France Germany Hungary Japan Netherlands Poland Russia Slovakia Spain Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1033

A Plain Language Trial Summary is available on novctrd.com

Other Identifiers

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2018-000993-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLOU064A2201

Identifier Type: -

Identifier Source: org_study_id

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