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Allergic AsthmaPhase 2/3AA007NCT01976208

Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

A Phase 2/3 study testing Omalizumab in people with Allergic Asthma, run by Shanghai Zhangjiang Biotechnology Limited Company at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma. Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
Allergic Asthma
What is being tested?
Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
27 sitesChina
Study dates
Dec 2010to Dec 2015
Phase
Phase 2/3
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 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female aged 15~65 years
  • Written informed consent provided
  • Total serum IgE >=60IU/ml
  • Duration of allergic asthma >= 1 year according to GINA(2008)
  • Poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
  • Agreed to be not pregnant, contraception during study and later 6 months.

Who cannot join

  • Patients who met the below criteria were excluded:
  • Be regular smokers(>10 cigarettes per day and for at least 2 years)
  • Patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
  • COPD, according to the guideline of Chinese society of respiratory diseases
  • An active lung disease other than allergic asthma
  • Patients with significant underlying medical conditions
Show all 10Show fewer
  • Allergic to immunoglobin or any formulation ingredient of the product
  • Patients with diabetes or uncontrolled hypertension(Systolic blood pressure>160mmHg or Diastolic blood pressure>95mmHg)
  • HIV positivity or cancer patient
  • Prior exposure to Xolair

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

  • Beijing Chaoyang Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The Second Hospital of Jilin University

    Changchun

  • West China Hospital, Sichuan University

    Chengdu

  • Chongqing Xinqiao Hospital

    Chongqing

  • Chinese PLA Fuzhou General Hospital of Nanjing Military Command

    Fuzhou

  • South Hospital of South Medical University

    Guangzhou

  • Sir Run Run Shaw Hospital of Zhejiang University

    Hangzhou

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou

  • Chinese PLA Jinan Military General Hospital

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • Jiangsu Province Hospital

    Nanjing

  • Zhongda Hospital, Southeast University

    Nanjing

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • Qingdao Municipal Hospital

    Qingdao

  • Shanghai Changzheng Hospital

    Shanghai

  • Shanghai First People's Hospital

    Shanghai

  • Zhongshan Hospital, Fudan University

    Shanghai

  • Chinese PLA Shenyang Military Command General Hospital

    Shenyang

  • The First hospital of China Medical University

    Shenyang

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

  • The Second Hospital of Tianjin Medica University

    Tianjin

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology

    Wuhan

  • Xi'an Xijing Hospital

    Xi'an

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Anti-IgE Monoclonal Antibody Injection(Omalizumab) in Patients With Allergic Asthma

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Read the detailed description

Omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with moderate or severe allergic asthma(IgE>=60IU/ml), who demonstrate inadequate asthma symptom control. Response to Omalizumab will be assessed by the overall improvement in control of asthma.

Omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E(IgE). The antibody has a molecular weight of approximately 150 kilodaltons and produced by Chinese Hamster Ovary cell.

Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction in surface-bound IgE on cells limits the degree of release of mediators of the allergic response.

Conditions
Allergic Asthma
Being tested
Omalizumab, placebo
Keywords
Omalizumab, IgE, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabDrug

    Also called other name: Aomaishu, Recombinant Humanized Anti-IgE Monoclonal Antibody

    The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg~750mg，then dosing interval is every 2 weeks.

  • placeboDrug

Study groups in NCT01976208
Study groupRoleWhat they receive
OmalizumabExperimentalDuring the 4~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the following treatment phase, patients continued to receive optimized BUD and Omalizumab for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks. The dosage of Omalizumab received was based on body weight and serum IgE.
Receives: Drug: Omalizumab
placeboPlacebo comparatorDuring the 4~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the treatment phase, patients continued to receive placebo and optimized BUD for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with asthma exacerbation

    Measured: 32 weeks

Secondary outcomes (2)

  1. Pulmonary function measured by FEV1 and FEV1/FVC

    Measured: 32 weeks

  2. Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2013 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976208
Sponsor's protocol ID
CMAB007
Acronym
AA007
Status last verified
Dec 2015
First submitted
23 Oct 2013
Last updated
22 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Omalizumab in people with Allergic Asthma, run by Shanghai Zhangjiang Biotechnology Limited Company at 27 sites in China.

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 6 inclusion and 10 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The proportion of patients with asthma exacerbation (time frame: 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976208.

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 22 Dec 2015.

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