Overview

This trial is active, not recruiting.

Condition chronic idiopathic urticaria
Treatments omalizumab, placebo
Phase phase 4
Target IgE
Sponsor Genentech, Inc.
Start date May 2015
End date March 2017
Trial size 206 participants
Trial identifier NCT02392624, ML29510

Summary

This randomized, double-blind, placebo-controlled study will evaluate efficacy and safety of subcutaneous omalizumab as an add-on therapy through 48 weeks. After completing an initial 24-week open-label treatment period with omalizumab 300 mg every 4 weeks, participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants in this arm will receive 300 milligrams (mg) omalizumab administered subcutaneously once every four weeks
omalizumab
(Placebo Comparator)
Participants in this arm will receive placebo injections administered subcutaneously once every four weeks
placebo

Primary Outcomes

Measure
Percentage of participants who experience clinical worsening in CIU as assessed by Urticaria Activity Score over 7 days (UAS7), where the threshold for clinical worsening is UAS7 is greater than or equal to 12 for at least 2 consecutive weeks
time frame: Randomization (Week 24) to Week 48 (Day 169 to Day 336)

Secondary Outcomes

Measure
Incidence and severity of adverse events; change in vital signs and clinical laboratory evaluations
time frame: From Day 1 in study through 112 days after the last administration of the study drug (approximately 5 drug half lives)
Time to clinical worsening in CIU
time frame: Randomization (Week 24) to Week 48 (Day 169 to Day 336)
Percentage of participants who experience clinical worsening in CIU as assessed by UAS7, where the threshold for clinical worsening is UAS7 greater than (>) 6 for at least 2 consecutive weeks
time frame: Randomization (Week 24) to Week 48 (Day 169 to Day 336)
Change from randomization to week 48 in UAS7, among participants who have responded to omalizumab at 24 weeks and completed a further 24 weeks of omalizumab
time frame: Randomization (Week 24) to Week 48 (Day 169 to Day 336)
Retreatment efficacy: change in UAS7 from time of retreatment to 12 weeks after retreatment in participants randomized to placebo and retreated with omalizumab after randomization and received at least 12 weeks of omalizumab therapy as retreatment
time frame: Randomization (Week 24) to Week 48 (Day 169 to Day 336)

Eligibility Criteria

Male or female participants from 12 years up to 75 years old.

Inclusion Criteria: - Adolescents and adults of age group 12-75 years - Diagnosis of CIU refractory to H1 antihistamines at baseline - Presence of itch and hives for at least 8 consecutive weeks before enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period - Receiving H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening - CIU diagnosis of greater than or equal to 6 months - Willing and able to complete a daily symptom eDiary for the duration of the study Exclusion Criteria: - Treatment with an investigational agent within 30 days of the initial screening visit - Body weight less than (<) 20 kilograms (kg) - Clearly defined underlying etiology for chronic urticarias other than CIU - Evidence of a parastic infection - Atopic dermatitis or other skin disease associated with pruritus - Previous treatment with omalizumab within 1 year prior to screening - Participants may not have taken during treatment period or have been taking within 30 days before screening any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, Intravenous Immunoglobulin G (IVIG) or plasmapheresis - Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening

Additional Information

Official title A Phase IV, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..