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New hope for cedar fever sufferers: drug eases severe allergy symptoms

NCT ID NCT03369704

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called omalizumab in 337 adults and teens with severe Japanese cedar pollen allergy (hay fever) that standard medicines couldn't control. Participants received either omalizumab or a placebo on top of their usual allergy treatments for 12 weeks. The goal was to see if the drug could better relieve nasal and eye symptoms during the worst part of the pollen season.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

337 people

The number who actually took part.

Started

Dec 2017

Finished

Oct 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * A clinical history of Japanese cedar pollinosis defined by the following * Took nasal corticosteroid plus one or more medications out of antihistamine (second generation), leukotriene receptor antagonist, or prostaglandin D2 thromboxane A2 receptor antagonist in Japanese cedar pollen seasons in 2016 and 2017. * Had inadequately controlled symptoms of Japanese cedar pollinosis lasting at least one week in the Japanese cedar pollen season in 2017 despite the nasal corticosteroid plus one or more medications out of anti-histamine (second generation), leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist (regardless of having perennial allergic rhinitis or not) * Serum cedar pollen-specific Immunoglobulin E (IgE) levels of ≥ score of 3 by CAP/RAST-FEIA, ImmunoCAP or MAST at the screening epoch. * Developing a symptom of Japanese cedar pollinosis during the period from first observational day in cedar pollen in Kanto area to initial drug administration (Visit 101), as defined by the following * Having any nasal or ocular symptom (≥ score of 1 in sneezing, rhinorrhea, nasal congestion, itchy eye or watery eye) in at least 2 days or * Having both any nasal symptom (≥ score of 1 in sneezing, rhinorrhea, nasal congestion) and any eye symptom (≥ score of 1 in itchy eye or watery eye) in at least one day, which is confirmed by patient e-diary (unless a symptom is clearly consider to take place due to other than Japanese cedar pollinosis/allergic rhinitis (e.g., upper respiratory tract infection, or common cold)). * Body weight and serum total IgE level at screen epoch within the dosing table range; body weight of ≥ 20 to ≤ 150 kg and serum total IgE levels of ≥ 30 to ≤ 1500 IU/mL at a maximum. Exclusion Criteria: * With an active rhinitis other than allergic rhinitis (e.g acute or chronic rhinitis, idiopathic rhinitis). * With an active nose disease other than allergic rhinitis (e.g., acute or chronic rhinosinusitis or deflected septum) which is expected to affect the evaluation of efficacy of the study drug judged by the investigator. * With elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or clinical allergic bronchopulmonary aspergillosis). * With a severe asthma treated with high dose inhaled corticosteroid (≥ 800 μg/day fluticasone propionate or an equivalent for aged ≥ 16 to \<75 years, \> 200 μg/day for aged ≥ 12 to \<16 years). * Who are receiving operative treatment for allergic rhinitis (e.g., electrocoagulation, laser surgery, 80% trichloroacetic acid chemo-surgery, inferior turbinectomy or posterior nasal neurectomy) within 1 years prior to the screening epoch.

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Conditions

The condition(s) this trial relates to.

seasonal allergic rhinitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Seasonal allergic rhinitis

Contacts and locations

Locations

  • Novartis Investigative Site

    Chiba, Chiba, 262-0015, Japan

  • Novartis Investigative Site

    Ichikawa, Chiba, 272-0143, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 2270082, Japan

  • Novartis Investigative Site

    Matsudo, Chiba, 270-0034, Japan

  • Novartis Investigative Site

    Matsudo, Chiba, 2710077, Japan

  • Novartis Investigative Site

    Urayasu, Chiba, 279-0012, Japan

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 212-0027, Japan

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216 0006, Japan

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216-0002, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, Japan

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-0031, Japan

  • Novartis Investigative Site

    Arakawa-ku, Tokyo, 116 0011, Japan

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-0063, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 103 0027, Japan

  • Novartis Investigative Site

    Edogawa-ku, Tokyo, 132-0014, Japan

  • Novartis Investigative Site

    Katsushika-ku, Tokyo, 125-0061, Japan

  • Novartis Investigative Site

    Nakano-ku, Tokyo, 164-0012, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 158-0097, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0008, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-0017, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, Japan

  • Novartis Investigative Site

    Toshima-Ku, Tokyo, 170-0005, Japan

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