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

• Status: Completed
• Trial end date: 2021-04-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Histamine Antagonists; Histamine H1 Antagonists

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.