A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LIGELIZUMAB (QGE031) IN THE TREATMENT OF CHRONICSPONTANEOUS URTICARIA (CSU) IN ADOLESCENTS AND ADULTS INADEQUATELY CONTROLLED WITH H1-ANTIHISTAMINES

Not Applicable

Recruiting

• Conditions: -L508 Other urticaria; Other urticaria; L508

• Registration Number: PER-035-18
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-28
• Study Completion: 2022-05-13
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1 Signed informed consent.
2 Subject’s parent’s / legal guardian’s signed written informed consent and child’s assent, if appropriate.
3 Male and female subjects more than 12 years at the time of screening.
4 CSU diagnosis for more than 6 months.
5 Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization.
6 Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
7 Subjects must not have had any missing eDiary entries in the 7 days (twice a day) prior to randomization (Day 1, Visit 110).

Exclusion Criteria

1 Other investigational drugs within 5 half-lives or 30 days prior to V1.
2 Hypersensitivity to any of the study drugs or excipients.
3 Clearly defined cause of chronic urticaria, other than CSU.
4 Diseases, other than chronic urticaria, with urticarial or angioedema symptoms.
5 Helminthic parasitic infection.
6 Any other skin disease associated with chronic itching.
7 Prior exposure to ligelizumab or omalizumab.
8 Any H2 antihistamine use after V1.
9 Any LTRA use after V1.
10 Any H1 antihistamines use at greater than approved doses after V1.
11 Alcohol or drug abuse.
12 Inability to comply with study and follow-up procedures.
13 Use of prohibited treatment.
14 Contraindications or hypersensitivity to fexofenadine, loratadine, cetirizine, rupatadine, epinephrine or any of their ingredients.
15 History of anaphylaxis.
16 Malignancy of any organ system within the past 5 years.
17 Clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions
18 Medical examination or laboratory findings.
19 Hepatic disease.
20 Renal disease or creatinine level above 1.5x ULN at V1
21 Platelets < 100 000/μL at V1.
22 Long QT syndrome at V1.
23. Pregnant or nursing (lactating) women.
24 Female subjects of childbearing unless they are using contraception for the duration of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified