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Completed

NCT Number: NCT03926611

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

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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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOU064 Arm 1

Drug

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

LOU064 Arm 2

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

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

Drug

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

LOU064 Arm 5

Drug

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

LOU064 Arm 6

Drug

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

Placebo arm

Drug

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: Week 12

    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.

  3. Cumulative Number of Weeks With an AAS7=0 Response

    Time frame: Baseline to Week 12

    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.

  4. Percentage of Participants With DLQI Score of 0 or 1

    Time frame: Week 4 and Week 12

    Percentage of subjects with DLQI 0/1 response by treatment group and visit (non-responder imputation)

    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.

  5. Mean Change From Baseline in DLQI Score

    Time frame: Baseline, Week 4 and Week 12

    Summary of DLQI score and change from baseline

    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).

  6. 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 .

  7. 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 .

  8. 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 Weeks 4 and 12

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2019
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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