UrticariaPhase 2NCT01987947
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
A Phase 2 study testing Quilizumab in people with Urticaria, run by Genentech, Inc. at 3 sites in 2 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urticaria
- What is being tested?
- Quilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following:
- The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period
- UAS7 score greater than 16 and itch component of UAS7 greater than 8 during 7 days prior to Day 1. Patients must have been on daily stable doses of H1 antihistamine for at least 3 consecutive days immediately prior to the screening visit and must document current use at screening
- CSU diagnosed for more than 6 months
- Patients must have a minimum diary compliance (6 out of 7 consecutive days) prior to Day 1
Who cannot join
- Treatment with an investigational agent within 30 days of screening, and previous treatment with monoclonal antibody therapies used to treat CSU 9 months prior to screening
- Chronic urticarias other than CSU, including the following: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact.
- Other diseases and conditions with symptoms of urticaria.
- Routine doses of the following medications within 30 days prior to screening: systemic or topical corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
- IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening
- Patients with cancer, history of cancer considered uncured or in complete remission for < 10 years, or currently under work-up for suspected cancer except non-melanoma skin cancer that has been treated or excised and is considered resolved
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- History of anaphylactic shock without clearly identifiable avoidable antigen
- Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions.
- Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
- Evidence of current drug or alcohol abuse
- Nursing women and women of childbearing potential, unless using effective contraception as defined by protocol
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.
- Conditions
- Urticaria
- Being tested
- Placebo, Quilizumab
- Keywords
- MEMP1972A
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Two administrations by subcutaneous injection
QuilizumabDrug
Two administrations by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Quilizumab | Active comparator | Not described Receives: Drug: Quilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
Measured: 21 weeks
Safety: Incidence & severity of adverse events.
Measured: Approximately 30 weeks
Safety: Incidence of anti-therapeutic antibodies.
Measured: Approximately 30 weeks
Secondary outcomes (2)
Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
Measured: 5 weeks
Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987947
- Sponsor's protocol ID
- GX29107
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT01987947
- Acronym / sponsor ID
- GX29107
- Conditions
- Urticaria
- Keywords
- MEMP1972A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Quilizumab | Active comparator | Drug: Quilizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following:
- The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period
- UAS7 score greater than 16 and itch component of UAS7 greater than 8 during 7 days prior to Day 1. Patients must have been on daily stable doses of H1 antihistamine for at least 3 consecutive days immediately prior to the screening visit and must document current use at screening
- CSU diagnosed for more than 6 months
- Patients must have a minimum diary compliance (6 out of 7 consecutive days) prior to Day 1
Key exclusion criteria (11 listed)
- Treatment with an investigational agent within 30 days of screening, and previous treatment with monoclonal antibody therapies used to treat CSU 9 months prior to screening
- Chronic urticarias other than CSU, including the following: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact.
- Other diseases and conditions with symptoms of urticaria.
- Routine doses of the following medications within 30 days prior to screening: systemic or topical corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
- IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening
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 |
|---|---|---|
| PlaceboTwo administrations by subcutaneous injection | Drug | Placebo |
| QuilizumabTwo administrations by subcutaneous injection | Drug | Quilizumab |
Primary outcome
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
Time frame: 21 weeks
Safety: Incidence & severity of adverse events.
Time frame: Approximately 30 weeks
Safety: Incidence of anti-therapeutic antibodies.
Time frame: Approximately 30 weeks
2 secondary outcomes
Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.
Time frame: 5 weeks
Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study director
Genentech, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quilizumab in people with Urticaria, run by Genentech, Inc. at 3 sites in 2 countries.
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 5 inclusion and 11 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score. (time frame: 21 weeks). The study lists 3 primary outcomes in all. 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 2 Nov 2016.