Dose-finding study to evaluate efficacy and safety of LOU064 in patients with CSU inadequately controlled by H1-antihistamines

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000993-31-FR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-26
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Male and female subjects aged =18 years of age
3. CSU diagnosis for = 6 months prior to screening
4. 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)
5. Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 286
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Hypersensitivity to any of the study treatments
2. Clearly defined, predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
3. Other diseases with symptoms of urticaria or angioedema
4. Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results
5. 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.
6. Pregnant or nursing (lactating) women
7. Women of child-bearing potential not using highly effective methods of contraception

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified