Chronic Idiopathic UrticariaPhase 2NCT00866788
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
A Phase 2 study testing omalizumab, H1 antihistamines and Diphenhydramine in people with Chronic Idiopathic Urticaria, run by Genentech, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- omalizumab, H1 antihistamines and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CIU diagnosis > 3 months (by history)
- No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
Who cannot join
- 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)
Show all 9Show fewer
- 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).
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
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.
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- omalizumab, placebo, H1 antihistamines, Diphenhydramine
- Keywords
- Xolair, CIU
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Also called Xolair
Administered by subcutaneous injection
placeboDrug
Participants received a single subcutaneous placebo injection on Day 0 of the study.
H1 antihistaminesDrug
Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
DiphenhydramineDrug
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab 75 mg | Experimental | 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.). Receives: Drug: omalizumab; Drug: H1 antihistamines; Drug: Diphenhydramine |
| Omalizumab 300 mg | Experimental | 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. Receives: Drug: omalizumab; Drug: H1 antihistamines; Drug: Diphenhydramine |
| Omalizumab 600 mg | Experimental | 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. Receives: Drug: omalizumab; Drug: H1 antihistamines; Drug: Diphenhydramine |
| Placebo | Placebo comparator | 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. Receives: Drug: omalizumab; Drug: placebo; Drug: H1 antihistamines; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
Measured: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Secondary outcomes (10)
Change in the Weekly Pruritus Score From Baseline to Week 4
The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.
Measured: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Number of Hives From Baseline to Week 4
The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.
Measured: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.
Measured: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.
Measured: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Number of Patients With Adverse Events by Severity
The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.
Additional AE data is provided in the AE section below. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE. A "Serious" AE is defined below.
Measured: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
Number of Participants With Immunogenicity
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
Measured: 16 weeks
Maximum Observed Concentration (Cmax) of Omalizumab
Cmax is the maximum (or peak) concentration of omalizumab in serum.
Measured: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Time to Maximum Concentration (Tmax) of Omalizumab
Tmax is the time to maximum concentration of omalizumab.
Measured: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
AUCinf is the area under the concentration-time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). Only participants having complete profiles and completed the study were included in the analysis.
Measured: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Terminal Half-Life (t1/2) of Omalizumab
Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.
Measured: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Rosen, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866788
- Sponsor's protocol ID
- Q4577g
- Status last verified
- Jun 2017
- First submitted
- 20 Mar 2009
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
- ClinicalTrials.gov ID
- NCT00866788
- Acronym / sponsor ID
- Q4577g
- Conditions
- Chronic Idiopathic Urticaria
- Keywords
- Xolair, CIU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 9 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omalizumab 75 mg | Experimental | Drug: omalizumab, Drug: H1 antihistamines, Drug: DiphenhydramineOmalizumab (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.). |
| Omalizumab 300 mg | Experimental | Drug: omalizumab, Drug: H1 antihistamines, Drug: DiphenhydramineOmalizumab (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. |
| Omalizumab 600 mg | Experimental | Drug: omalizumab, Drug: H1 antihistamines, Drug: DiphenhydramineOmalizumab (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. |
| Placebo | Placebo comparator | Drug: omalizumab, Drug: placebo, Drug: H1 antihistamines, Drug: DiphenhydramineParticipants 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- CIU diagnosis > 3 months (by history)
- No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumabAlso: XolairAdministered by subcutaneous injection | Drug | Omalizumab 300 mg, Omalizumab 600 mg, Omalizumab 75 mg, Placebo |
| placeboParticipants received a single subcutaneous placebo injection on Day 0 of the study. | Drug | Placebo |
| H1 antihistaminesPatients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD | Drug | Omalizumab 300 mg, Omalizumab 600 mg, Omalizumab 75 mg, Placebo |
| DiphenhydramineDiphenhydramine was provided and used on an as-needed basis (25 mg per dose) | Drug | Omalizumab 300 mg, Omalizumab 600 mg, Omalizumab 75 mg, Placebo |
Primary outcome
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
10 secondary outcomes
Change in the Weekly Pruritus Score From Baseline to Week 4
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Number of Hives From Baseline to Week 4
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Number of Patients With Adverse Events by Severity
Time frame: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
Number of Participants With Immunogenicity
Time frame: 16 weeks
Maximum Observed Concentration (Cmax) of Omalizumab
Time frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Time to Maximum Concentration (Tmax) of Omalizumab
Time frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
Time frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Terminal Half-Life (t1/2) of Omalizumab
Time frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Rosen, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omalizumab, H1 antihistamines and Diphenhydramine in people with Chronic Idiopathic Urticaria, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 (time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.