A Phase 3 interventional study of Omalizumab and Placebo in Seasonal Allergic Rhinitis, sponsored by Novartis Pharmaceuticals. Completed at 22 sites in Japan. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 11 studies in Rhinitis, Allergic, Seasonal by Novartis — none open to participants now, none under way, none of them phase 3. Rhinitis, Allergic, Seasonal · Novartis.
Among the 11 studies in Rhinitis, Allergic, Seasonal by Novartis, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 5 in phase 3, and was the 7th registered.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
Browse Rhinitis, Allergic, Seasonal studies →None of the 11 studies in Rhinitis, Allergic, Seasonal by Novartis is open now. The open studies under Rhinitis, Allergic, Seasonal, anywhere →
Of the 17 Rhinitis, Allergic, Seasonal studies recruiting now, 2 (12%) set no upper age limit and 15 (88%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 12 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 5
First in 2006; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 337 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Median enrollment 191 across the 10 interventional studies, 50 across the 1 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Rhinitis, Allergic, Seasonal by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids plus one or more medications out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist) in the previous 2 Japanese cedar pollen seasons.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A clinical history of Japanese cedar pollinosis defined by the following
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks
Drug: Omalizumab
Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks
Drug: Placebo
Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
Mean Nasal Symptom Score
Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point). Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum.
Time frame: Severe symptom period (from 23Feb2018 to 24March2018)
Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score
Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point). Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score. Nasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome.
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score
Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period. Nasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion
Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Severity of Itchy and Watery Eye
Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Impairment of Daily Activities
Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Number of Symptom Free Days
Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.
Time frame: Severe symptom period (from 23Feb2018 to 24March2018)
Completely Nasal Symptom Free Patients
Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Rescue Medication Score
Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point). Rescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Rescue Medication Free Days
Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride). Nasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Number of Rescue Medication Used
Amount number of rescue medication used (a total number of times used).
Time frame: Severe symptom period (from 23Feb2018 to 24Mar2018)
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score
Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.
Time frame: Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient
Number of Participants With Anti-omalizumab Antibodes
Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.
Time frame: Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
Serum Trough Omalizumab Concentration
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
Time frame: Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose
Free IgE and Total IgE
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch
Time frame: Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose
This study was conducted at 22 centers in Kanto-area of Japan.
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 162 | 175 |
| Completed | 158 | 172 |
| Not completed | 4 | 3 |
| Withdrew: Technical problems | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Adverse event | 2 | 0 |
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 161 | 174 |
| Completed | 160 | 174 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point). Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum.
| score | Omalizumab | Placebo |
|---|---|---|
| Mean Nasal Symptom Score | 3.66 ± 0.151 | 4.69 ± 0.144 |
Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point). Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score. Nasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome.
| Score | Omalizumab | Placebo |
|---|---|---|
| Mean ocular symptom score | 2.45 ± 0.115 | 3.32 ± 0.110 |
| Mean nasal ocular symptom score | 6.11 ± 0.240 | 8.01 ± 0.228 |
Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period. Nasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride).
| score | Omalizumab | Placebo |
|---|---|---|
| Mean nasal symptom medication score | 6.19 ± 0.166 | 7.29 ± 0.158 |
| Mean ocular symptom medication score | 3.91 ± 0.137 | 4.86 ± 0.130 |
| Mean nasal ocular symptom medication score | 9.10 ± 0.271 | 11.15 ± 0.259 |
Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).
| score | Omalizumab | Placebo |
|---|---|---|
| Mean sneezing score | 1.15 ± 0.053 | 1.56 ± 0.050 |
| Mean rhinorrhea score | 1.46 ± 0.063 | 1.79 ± 0.060 |
| Mean nasal congestion score | 1.05 ± 0.058 | 1.34 ± 0.056 |
Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).
| score | Omalizumab | Placebo |
|---|---|---|
| Mean itchy eye score | 1.47 ± 0.061 | 1.94 ± 0.058 |
| Mean watery eye score | 0.98 ± 0.063 | 1.38 ± 0.060 |
Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).
| score | Omalizumab | Placebo |
|---|---|---|
| Mean Score for Impairment of Daily Activities | 1.09 ± 0.052 | 1.43 ± 0.050 |
Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.
| days | Omalizumab | Placebo |
|---|---|---|
| Nasal symptom free days | 15 (0 to 30) | 10 (0 to 30) |
| Ocular symptom free days | 12 (0 to 30) | 6 (0 to 30) |
Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.
| Participants | Omalizumab | Placebo |
|---|---|---|
| Completely Nasal Symptom Free Patients | 13 | 4 |
Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point). Rescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid
| score | Omalizumab | Placebo |
|---|---|---|
| Nasal rescue medication score | 0.20 ± 0.024 | 0.28 ± 0.023 |
| Ocular rescue medication score | 0.46 ± 0.029 | 0.54 ± 0.027 |
| Nasal ocular rescue medication score | 0.66 ± 0.045 | 0.82 ± 0.043 |
Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride). Nasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication).
| days | Omalizumab | Placebo |
|---|---|---|
| Nasal rescue medication free days | 27.0 (0 to 30) | 23.5 (0 to 30) |
| Ocular rescue medication free days | 16.0 (0 to 30) | 11.0 (0 to 30) |
| Nasal ocular rescue medication free days | 12.5 (0 to 30) | 9.0 (0 to 30) |
Amount number of rescue medication used (a total number of times used).
| Number of times used | Omalizumab | Placebo |
|---|---|---|
| Number of rescue nasal medication used | 1.0 (0 to 120) | 6.0 (0 to 109) |
| Number of ocular rescue medication used | 18.5 (0 to 109) | 28.5 (0 to 113) |
Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.
| Score | Omalizumab | Placebo |
|---|---|---|
| Nasal and eye symptoms (JRQLQ I) | 1.27 ± 0.062 | 1.76 ± 0.059 |
| Mean score of QoL-related questionnaire (JRQLQ II) | 0.70 ± 0.067 | 1.20 ± 0.064 |
| Overall face scale (JRQLQ III) | 1.6 ± 0.08 | 2.2 ± 0.07 |
Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.
| participants | Omalizumab | Placebo |
|---|---|---|
| Anti-Fab-(pre-dose) | 0 | 0 |
| Anti-Fab (post dose) | 0 | 0 |
| Anti-Fc-(pre-dose) | 1 | 2 |
| Anti-Fc-(post-dose) | 0 | 2 |
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
| μg/mL | Omalizumab |
|---|---|
| Day 1 (pre-dose) | 0 ± 0 |
| Day 29 | 42.6 ± 34.8 |
| Day 57 | 54.1 ± 42.3 |
| Day 85 | 66.3 ± 49.0 |
| Day 225/239 | 0.928 ± 1.11 |
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch
| ng/mL | Omalizumab | Placebo |
|---|---|---|
| Free IgE (Day 1 predose) | NA ± NA | NA ± NA |
| Free IgE (Day 29) | 21.3 ± 9.8 | NA ± NA |
| Free IgE (Day 57) | 20.8 ± 10.1 | NA ± NA |
| Free IgE (Day 85) | 18.6 ± 11.9 | NA ± NA |
| Free IgE (Day 225/239) | NA ± NA | NA ± NA |
| Total IgE (Day 1 pre-dose) | 524 ± 531 | 570 ± 641 |
| Total IgE (Day 29) | 2040 ± 1620 | 558 ± 608 |
| Total IgE (Day 57) | 2160 ± 1660 | 640 ± 721 |
| Total IgE (Day 85) | 1960 ± 1480 | 673 ± 775 |
| Total IgE (Day 225/239) | 702 ± 639 | 669 ± 783 |
Collected over Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IGE025 | 0/161 (0%) | 1/161 (0.6%) | 26/161 (16.1%) |
| Placebo | 0/175 (0%) | 0/175 (0%) | 21/175 (12%) |
| Event | IGE025 | Placebo |
|---|---|---|
| Testicular neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/161 | 0/175 |
| Event | IGE025 | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 15/161 | 8/175 |
| InfluenzaInfections and infestations | 4/161 | 8/175 |
| PharyngitisInfections and infestations | 7/161 | 5/175 |
Randomized set (RAN): The RAN included all randomized patients, regardless of whether they received any study drug. Patients in the RAN was analyzed according to the treatment assigned at randomization.
| Age, Customized(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| < 15 years | 4 | 6 | 10 |
| 15 <=, < 65 years | 149 | 158 | 307 |
| >= 65 years | 9 | 11 | 20 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Female | 99 | 97 | 196 |
| Male | 63 | 78 | 141 |
| Race/Ethnicity, Customized(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Asian | 162 | 175 | 337 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Dec 2017 to primary completion in May 2018, 4 months.
Results were first posted in Nov 2019, 1 year 5 months after primary completion.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, Seasonal, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 4 months is close to that.
Counting every sponsor, half of 37 studies reached it within 4 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab
Rhinitis, Allergic, Seasonal →