A multicenter, randomized, double-blind, placebocontrolled Phase 2b dose-finding study to investigate the efficacy, safety and tolerability of LOU064 in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines

Phase 2

Completed

• Conditions: hives; wheals; 10002426

• Registration Number: NL-OMON48501
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Signed informed consent must be obtained prior to participation in the study
- Male and female subjects aged *18 years of age
- CSU diagnosis for * 6 months prior to screening
- Diagnosis of CSU inadequately controlled by second generation
H1-antihistamines at the time of randomization as defined in the following:
- The 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to characterize the dose-response<br /><br>relationship of LOU064 administered once or twice daily in subjects with CSU<br /><br>with respect to change from baseline in UAS7 at Week 4</p><br>