A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

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Genentech

Status and phase

Completed
Phase 2

Conditions

Chronic Idiopathic Urticaria

Treatments

Drug: omalizumab
Drug: Diphenhydramine
Drug: H1 antihistamines
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866788
Q4577g

Details and patient eligibility

About

The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.

Enrollment

90 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • CIU diagnosis > 3 months (by history)
  • No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)

Exclusion criteria

  • Pregnant, breastfeeding, or women not taking contraception
  • Patients < 40kg
  • Treatment with any investigational agent within 30 days of screening
  • Recent history of drug or alcohol abuse
  • Atopic dermatitis or other skin disease associated with pruritus
  • Clinically relevant major systemic disease (making interpretation of the study results difficult)
  • Previously treated with omalizumab (< 12 months since last injection)
  • Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
  • Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 4 patient groups, including a placebo group

Omalizumab 75 mg
Experimental group
Description:
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
Treatment:
Drug: H1 antihistamines
Drug: Diphenhydramine
Drug: omalizumab
Omalizumab 300 mg
Experimental group
Description:
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Treatment:
Drug: H1 antihistamines
Drug: Diphenhydramine
Drug: omalizumab
Omalizumab 600 mg
Experimental group
Description:
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Treatment:
Drug: H1 antihistamines
Drug: Diphenhydramine
Drug: omalizumab
Placebo
Placebo Comparator group
Description:
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Treatment:
Drug: placebo
Drug: H1 antihistamines
Drug: Diphenhydramine
Drug: omalizumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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