Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

NCT02329223 | Completed Phase 3 Results

• 1 other identifier: CIGE025E2306
• Study Type: interventional
• Target: 218
• Locations: 2 countries
• Sites: 39

Brief Summary

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Conditions

Chronic Spontaneous Uriticaria

Keywords

Chronic spontaneous uriticaria; Omalizumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Itch Severity Score at Week 12

  The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.

  Baseline to Week 12

Secondary Outcomes (8)

• Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12

  Baseline to Week 12

• Change From Baseline in the Weekly Number of Hives Score at Week 12

  Baseline to Week 12

• Percentage of Participants With a UAS7 Score ≤ 6 at Week 12

  Week 12

• Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12

  Baseline to Week 12

• Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12

  Week 12

Study Arms (3)

Omalizumab 300 mg

EXPERIMENTAL

Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

Biological: Omalizumab

Omalizumab 150 mg

EXPERIMENTAL

Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

Biological: Omalizumab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

Other: Placebo

Interventions

Omalizumab BIOLOGICAL

Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

Also known as: Xolair

Omalizumab 150 mg; Omalizumab 300 mg

Placebo OTHER

Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
• Chronic spontaneous urticaria diagnosis for 6 months

You may not qualify if:

• Weight less than 20 kg
• Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
• Evidence of parasitic infection
• Any other skin diseases than chronic spontaneous urticaria with chronic itching
• Previous treatment with omalizumab
• Contraindications to diphenhydramine
• History of anaphylactic shock
• History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
• History of hypersensitivity to omalizumab or to drugs of similar chemical classes
• Pregnant or nursing (lactating) women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (39)

Novartis Investigative Site

Toyoake, Aichi-ken, 470-1192, Japan

Location

Novartis Investigative Site

Hiroshima, Hiroshima, 734-8551, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 663-8186, Japan

Location

Novartis Investigative Site

Hitachi, Ibaraki, 317-0077, Japan

Location

Novartis Investigative Site

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 213-8507, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0825, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0868, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0004, Japan

Location

Novartis Investigative Site

Yokosuka, Kanagawa, 238-8558, Japan

Location

Novartis Investigative Site

Kamimashi-gun, Kumamoto, 861-3101, Japan

Location

Novartis Investigative Site

Nagano, Nagano, 381-8551, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 532-0003, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 593-8324, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 330-0854, Japan

Location

Novartis Investigative Site

Izumo, Shimane, 693-8501, Japan

Location

Novartis Investigative Site

Kodaira, Tokyo, 187-8510, Japan

Location

Novartis Investigative Site

Machida, Tokyo, 194-0013, Japan

Location

Novartis Investigative Site

Meguro-ku, Tokyo, 153-8515, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 107-6206, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143-0023, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Novartis Investigative Site

Kofu, Yamanashi, 400-8506, Japan

Location

Novartis Investigative Site

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Novartis Investigative Site

Hwaseong-si, Gyeonggi-do, 445-170, South Korea

Location

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06591, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 152-703, South Korea

Location

Novartis Investigative Site

Seoul, Seoul, 156-755, South Korea

Location

Novartis Investigative Site

Busan, 602-715, South Korea

Location

Novartis Investigative Site

Daegu, 705-703, South Korea

Location

Novartis Investigative Site

Gwangju, 501-757, South Korea

Location

Novartis Investigative Site

Incheon, 405-760, South Korea

Location

Novartis Investigative Site

Seoul, 120-752, South Korea

Location

Novartis Investigative Site

Seoul, 130-872, South Korea

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 21, 2016
• Results First Posted: September 20, 2016

Record last verified: 2016-09

Locations

KR (14); JP (25)