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

  • Clinicaltrials.gov identifier

    NCT03926611

  • Recruitment Status

    Completed

  • First Posted

    April 24, 2019

  • Last update posted

    May 17, 2021

Study Description

Brief summary:

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 or Disease:Chronic Spontaneous Urticaria
  • Intervention/Treatment: Drug: LOU064 Arm 5
    Drug: LOU064 Arm 1
    Drug: LOU064 Arm 2
    Drug: LOU064 Arm 3
    Drug: LOU064 Arm 4
    Drug: LOU064 Arm 6
    Drug: Placebo arm
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 311 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: January 2021
  • Actual Study Completion Date: April 2021

Arms and interventions

Arm Intervention/treatment
Experimental: LOU064 Arm 1
Participants will be asked to take LOU064 low dose once daily
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
Experimental: LOU064 Arm 2
Participants will be asked to take LOU064 medium dose once daily
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
Experimental: LOU064 Arm 3
Participants will be asked to take LOU064 high dose once daily
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
Experimental: LOU064 Arm 4
Participants will be asked to take LOU064 low dose twice daily
Drug: LOU064 Arm 4
Low dose of LOU064 orally, twice daily from Day 1 to 85
Experimental: LOU064 Arm 5
Participants will be asked to take LOU064 medium dose twice daily
Drug: LOU064 Arm 5
Medium dose of LOU064 orally, twice daily from Day 1 to 85
Experimental: LOU064 Arm 6
Participants will be asked to take LOU064 high dose twice daily
Drug: LOU064 Arm 6
High dose of LOU064 orally, twice daily from Day 1 to 85
Placebo Comparator: Placebo Arm
Participants will be asked to take matching placebo twice daily
Drug: Placebo arm
Matching placebo, orally, twice daily from Day 1 to 85

Outcome Measures

  • Primary Outcome Measures: 1. Change from baseline in weekly Urticaria Activity Score (UAS7) [ Time Frame: Week 4 ]
    The primary objective of this study is to characterize the dose-response relationship of LOU064 administered once or twice daily in subjects with CSU with respect to change from baseline in UAS7 at Week 4. The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
  • Secondary Outcome Measures: 1. Change from baseline in weekly Urticaria Activity Score (UAS7) [ Time Frame: Week 12 ]
    The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
  • 2. Change from baseline in weekly Urticaria Activity Score (UAS7) [ Time Frame: Over time from week 1 to week 16 ]
    The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
  • 3. Complete absence of hives and itch (UAS7=0) [ Time Frame: Over time from week 1 to week 16 ]
    The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity). A complete absence of hives and itches over a week is defined as UAS7=0.
  • 4. Disease control (UAS7<=6) [ Time Frame: Over time from week 1 to week 16 ]
    The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity). Disease control is defined as UAS7<=6.
  • 5. Cumulative number of weeks with an AAS7=0 response [ Time Frame: Baseline to Week 12 ]
    The 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 higher severity.
  • 6. DLQI score of 0 or 1 [ Time Frame: Week 4 and Week 12 ]
    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
  • 7. Change from baseline in DLQI score [ Time Frame: Week 4 and Week 12 ]
    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL).
  • 8. Area under the blood concentration-time curve (AUC) of LOU064 [ Time Frame: Week 4 and Week 12 ]
    Assessment of the area under the blood concentration-time curve (AUC)up to four hours following oral administration at Week 4 and Week 12 .
  • 9. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Over time from week 1 to week 16 ]
    Safety endpoints will include but not be limited to: occurrence of treatment emergent (serious and non-serious) adverse events.
  • 10. Observed maximum blood concentration (Cmax) of LOU064 [ Time Frame: Week 4 and Week 12 ]
    Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 .
  • 11. Time to reach the maximum concentration (Tmax) of LOU064 [ Time Frame: Week 4 and Week 12 ]
    Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Week 4 and Week 12 .

Eligibility Criteria

  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Locations

United States, Arizona
Novartis Investigative Site
Litchfield Park

United States, Arkansas
Novartis Investigative Site
Little Rock

United States, California
Novartis Investigative Site
Mission Viejo

United States, California
Novartis Investigative Site
San Diego

United States, California
Novartis Investigative Site
Walnut Creek

United States, California
Novartis Investigative Site
Westminster

United States, Florida
Novartis Investigative Site
Pembroke Pines

United States, Kentucky
Novartis Investigative Site
Owensboro

United States, Michigan
Novartis Investigative Site
Ypsilanti

United States, Missouri
Novartis Investigative Site
Saint Louis

United States, Ohio
Novartis Investigative Site
Grove City

Argentina, Buenos Aires
Novartis Investigative Site
Caba

Argentina, Buenos Aires
Novartis Investigative Site
La Plata

Argentina, Mendoza
Novartis Investigative Site
Ciudad de Mendoza

Argentina
Novartis Investigative Site
Caba

Belgium, Antwerpen
Novartis Investigative Site
Edegem

Belgium
Novartis Investigative Site
Liege

Canada, Alberta
Novartis Investigative Site
Edmonton

Canada, Ontario
Novartis Investigative Site
London

Canada, Ontario
Novartis Investigative Site
Niagara Falls

Canada, Ontario
Novartis Investigative Site
Ottawa

Canada, Quebec
Novartis Investigative Site
Verdun

Canada
Novartis Investigative Site
Quebec

Czechia, Czech Republic
Novartis Investigative Site
Prague 8

Czechia, Prague 1
Novartis Investigative Site
Prague

Czechia
Novartis Investigative Site
Tabor

Denmark
Novartis Investigative Site
Arhus C

Denmark
Novartis Investigative Site
Copenhagen NV

France
Novartis Investigative Site
Lille Cedex

France
Novartis Investigative Site
Nantes

France
Novartis Investigative Site
Nice

France
Novartis Investigative Site
Pierre Benite Cedex

France
Novartis Investigative Site
Rouen

Germany
Novartis Investigative Site
Berlin

Germany
Novartis Investigative Site
Dresden

Germany
Novartis Investigative Site
Gera

Germany
Novartis Investigative Site
Hannover

Germany
Novartis Investigative Site
Muenchen

Hungary, Hajdu Bihar
Novartis Investigative Site
Debrecen

Hungary
Novartis Investigative Site
Budapest

Hungary
Novartis Investigative Site
Debrecen

Hungary
Novartis Investigative Site
Oroshaza

Hungary
Novartis Investigative Site
Pecs

Hungary
Novartis Investigative Site
Szolnok

Japan, Aichi
Novartis Investigative Site
Ichinomiya

Japan, Chiba
Novartis Investigative Site
Funabashi

Japan, Hokkaido
Novartis Investigative Site
Obihiro

Japan, Kanagawa
Novartis Investigative Site
Yokohama

Japan, Kanagawa
Novartis Investigative Site
Yokohama

Japan, Kanagawa
Novartis Investigative Site
Yokohama

Japan, Tokyo
Novartis Investigative Site
Itabashi-ku

Japan, Tokyo
Novartis Investigative Site
Koto

Japan, Toyama
Novartis Investigative Site
Takaoka

Japan
Novartis Investigative Site
Hiroshima

Netherlands
Novartis Investigative Site
Amsterdam

Netherlands
Novartis Investigative Site
Utrecht

Poland
Novartis Investigative Site
Gdansk

Poland
Novartis Investigative Site
Lodz

Poland
Novartis Investigative Site
Lodz

Poland
Novartis Investigative Site
Rzeszow

Poland
Novartis Investigative Site
Warszawa

Poland
Novartis Investigative Site
Wroclaw

Russian Federation
Novartis Investigative Site
Moscow

Russian Federation
Novartis Investigative Site
St Petersburg

Russian Federation
Novartis Investigative Site
St.-Petersburg

Russian Federation
Novartis Investigative Site
Stavropol

Slovakia, Slovak Republic
Novartis Investigative Site
Kosice

Slovakia
Novartis Investigative Site
Nove Zamky

Slovakia
Novartis Investigative Site
Svidnik

Spain, Cataluna
Novartis Investigative Site
Barcelona

Spain, Catalunya
Novartis Investigative Site
Barcelona

Spain, Catalunya
Novartis Investigative Site
Barcelona

Spain, Comunidad Valenciana
Novartis Investigative Site
Alicante

Spain
Novartis Investigative Site
Madrid

Spain
Novartis Investigative Site
Madrid

Turkey, TUR
Novartis Investigative Site
Istanbul

Turkey
Novartis Investigative Site
Denizli

Turkey
Novartis Investigative Site
Talas / Kayseri

United Kingdom
Novartis Investigative Site
Leeds

United Kingdom
Novartis Investigative Site
London

United Kingdom
Novartis Investigative Site
Oxford

United Kingdom
Novartis Investigative Site
Plymouth

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

More Information

  • Responsible Party: Novartis Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03926611 History of Changes
  • Other Study ID Numbers: CLOU064A2201
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: May 17, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Novartis Pharmaceuticals: BTK inhibitor
    Urticaria Activity Score
    Angioedema Activity Score
  • Additional relevant MeSH terms: Urticaria