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EU Clinical Trial 2018-001387-39 – EMA – Mar 15, 2019

A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)

Main objective of the trial: To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during ≥16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (...
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EU Clinical Trial 2017-001205-33 – EMA – Mar 14, 2019

A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26-Year-Old Females and Males in Vietnam

Main objective of the trial: In 9- to 26-year-old female and male participants: To demonstrate that the 9vHPV vaccine is immunogenic
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EU Clinical Trial 2017-000521-13 – EMA – Mar 12, 2019

Double-blind, randomised clinical study comparing efficacy and safety of Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 30 mg/g) (Test) vs. DUAC®10 mg/g + 30 mg/g Gel (Reference) vs. Vehicle in patients with papulopustular acne

Main objective of the trial: Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 30 mg/g Benzoyl peroxide vs. the orginator DUAC(R) 10 mg/g + 30 mg/g Gel (Reference) vs. vehicle in patients with papulopustular acne
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EU Clinical Trial 2018-004852-39 – EMA – Mar 12, 2019

Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

Main objective of the trial: To assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications (Clavien-Dindo >2) within 30 days after elective curative-intent surgery for digestive cancer. Evalue...
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EU Clinical Trial 2017-000981-31 – EMA – Mar 11, 2019

Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer.

Main objective of the trial: To determine if treatment with atezolizumab (arm B) is superior to a treatment without atezolizumab (arm A) in the improvement of 5-year Event-Free Survival (EFS). In case of superiority of arm B vs. arm A, a formal compa...
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EU Clinical Trial 2018-000349-38 – EMA – Mar 8, 2019

I4V-MC-JAIP A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Main objective of the trial: The primary objective of the study is to demonstrate the superiority of each dose of baricitinib to placebo in the treatment of patients with moderate to severe AD. Primary Objective for PK lead-in Period is to assess whe...
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EU Clinical Trial 2017-005076-26 – EMA – Mar 8, 2019

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Main objective of the trial: This study will evaluate the antitumor activity, safety, and pharmacokinetics (PK) of tisotumab vedotin in patients with locally advanced or metastatic tumors.
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EU Clinical Trial 2016-004463-39 – EMA – Mar 6, 2019

Influence on cough and airway symptoms by oral capsaicin (capscium oleoresin ) – a phase II, randomised, placebo-controlled clinical study in patients with chronic idiopathic cough

Main objective of the trial: To establish whether an oral intake of capsicum oleoresin; capsaicinoids expressed as 0,4 mg capsaicin (C18H27N03; M, 305.4) (from chili extract) can desensitise the cough reflex and improve unexplained coughing.
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EU Clinical Trial 2017-004776-56 – EMA – Mar 6, 2019

Phase IIa Biomarker Study to Evaluate the Efficacy, Safety and Tolerability of AT-1 in Patients with Hereditary Cystatin C Amyloid Angiopathy (HCCAA) - the AT1-HCCAA study

Main objective of the trial: • Evaluate safety and tolerability of AT-1 administered orally in adults (ages 18 and over) with HCCAA with or without dementia symptoms • Assess dose-response relationship of AT-1 on HCCAA disease progression, including...
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EU Clinical Trial 2018-002821-45 – EMA – Mar 5, 2019

Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects

Main objective of the trial: To assess the long-term safety and tolerability of macitentan in Fontan-palliated adult and adolescent subjects.
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EU Clinical Trial 2015-001192-48 – EMA – Mar 4, 2019

Traitement du ptosis des dystrophies musculaires oculo-pharyngées par autogreffes de myoblastes.

Main objective of the trial: amélioration du ptosis amélioration du ptosis
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EU Clinical Trial 2018-003453-16 – EMA – Mar 1, 2019

A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)

Main objective of the trial: Primary: To evaluate the efficacy of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in adult and pediatric subjects (aged 12 to <18 yea...
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EU Clinical Trial 2017-001611-37 – EMA – Feb 27, 2019

A 52 week prospective randomized controlled study to investigate the effect of intramuscular testosterone undecanoate supplementation vs placebo on intrahepatic fat content in obese men with uncontrolled type 2 diabetes (T2DM) suffering from hypogonadism with a subsequent 108 week open label phase to investigate long term effects on lipid distribution and cardiometabolic parameters in all participating men.

Main objective of the trial: • to identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes on intrahepatic fat content assessed as change from baseline to follow up
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EU Clinical Trial 2018-001661-17 – EMA – Feb 27, 2019

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

Main objective of the trial: - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo. - To evaluate the consistency of response to lasmiditan 200 mg and 100 mg compared to placebo. -Comparar la...
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EU Clinical Trial 2018-002823-41 – EMA – Feb 27, 2019

A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical treatment Chronic Thromboembolic Pulmonary Hypertension.

Main objective of the trial: The primary objective of the study is to evaluate the effect of selexipag on pulmonary vascular resistance (PVR) versus placebo in subjects with inoperable CTEPH and persistent/recurrent CTEPH after surgical treatment (pu...
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EU Clinical Trial 2018-001039-29 – EMA – Feb 26, 2019

A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, CONTROLLED STUDY INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH CHOP OR CHP-POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA

Main objective of the trial: Phase Ib Mosunetuzumab + cyclophosphamide, doxorubicin, vincristine, prednisone (M-CHOP): •To evaluate safety, tolerability of M-CHOP in patients with relapsed or refractory (R/R) B-cell NHL including estimation of the ma...
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EU Clinical Trial 2017-003364-12 – EMA – Feb 25, 2019

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

Main objective of the trial: To evaluate the effectiveness of niraparib plus AA-P compared to AA-P plus placebo.
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EU Clinical Trial 2017-000806-39 – EMA – Feb 25, 2019

A phase 1/2 open-label safety and dose-finding study of BAY 2599023 (DTX201), an adeno-associated virus (AAV) hu37-mediated gene transfer of B-domain deleted human factor VIII, in adults with severe hemophilia A

Main objective of the trial: Investigate the safety and tolerability of single ascending intravenous (IV) doses of BAY 2599023 (DTX2ß1) in adult patients with severe hemophilia A, who have been previously treated with FVIII product
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EU Clinical Trial 2018-002643-28 – EMA – Feb 25, 2019

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction.

Main objective of the trial: 1. To investigate heterogeneity in tumor uptake of [18F]BMS-986192 between patients and within tumor lesions of the same patient (primary tumor and TDLN/lymph node metastases) before treatment, in relation to changes in [...
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EU Clinical Trial 2018-001874-89 – EMA – Feb 25, 2019

Randomised controlled multicentre study of albumin replacement therapy in septic shock

Main objective of the trial: To investigate whether albumin administration and maintenance of serum albumin concentrations of at least 30 g/L in the ICU for up to 28 days after the onset of septic shock, will reduce total 90-day mortality compared to...
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EU Clinical Trial 2018-004707-40 – EMA – Feb 25, 2019

Verorab® immunogenicity and safety after a one week, 4-site, intradermal (ID) post-exposure prophylaxis regimen (4-4-4-0-0) followed by a one visit, 4-site, ID booster at five years.

Main objective of the trial: •To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen.
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EU Clinical Trial 2017-003221-15 – EMA – Feb 25, 2019

PROSPEKTIV RANDOMISIERTE, MULTIZENTRISCHE STUDIE ZUM VERGLEICH DER EINER RADIKALEN HYSTEREKTOMIE NACH NEOADJUVANTER CHEMOTHERAPIE VERSUS EINER PRIMÄREN RADIOCHEMOTHERAPIE BEI PATIENTINNEN MIT EINEM ZERVIXKARZINOM DER FIGO- STADIEN IB2 UND IIB

Main objective of the trial: Überlegenheit bzgl. Wirksamkeit (Disease Free Survival, DFS) der Therapie eines der beiden Arme: Radikale Hysterektomie nach NACT mit Carboplatin, Paclitaxel (TP) bzw. Cisplatin, Paclitaxel, Ifosfamid (TIP) versus primäre...
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EU Clinical Trial 2017-004758-40 – EMA – Feb 22, 2019

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

Main objective of the trial: Dose escalation: To establish the MTD and RP2D of tisotumab vedotin in combination in subjects with cervical cancer Dose expansion: Evaluate the antitumor activity of tisotumab vedotin in combination in subjects with cerv...
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EU Clinical Trial 2018-002133-37 – EMA – Feb 22, 2019

A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness

Main objective of the trial: To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.
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EU Clinical Trial 2017-004752-34 – EMA – Feb 20, 2019

Study of pembrolizumab combined with ataluren in Patients with metastatic pMMR and dMMR colorectal cancer adenocarcinomas or metastatic dMMR endometrial carcinoma: the ATAPEMBRO study.

Main objective of the trial: 1. To assess safety and characterize toxicities of pembrolizumab combined with ataluren in patients with pMMR mCRC, dMMR mCRC and dMMR mEC. 2. To determine the immune-related progression free survival (irPFS) rate at 21 w...
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EU Clinical Trial 2017-001747-12 – EMA – Feb 20, 2019

A phase 2, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, with or without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups of Pediatric Sickle Cell Disease Patients with Vaso-Occlusive Crisis

Main objective of the trial: - To confirm and establish appropriate dosing of crizanlizumab in patients ages 6 months to <18 years at the time of study entry (Part A and B) - To evaluate the safety of crizanlizumab in patients ages 6 months to <18 ye...
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EU Clinical Trial 2018-003794-98 – EMA – Feb 20, 2019

A Phase 3, randomized, double-blind trial of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) in participants with treatment-naïve, metastatic non-small cell lung cancer (NSCLC) whose tumors have a tumor proportion score (TPS) greater than or equal to 1% (LEAP-007)

Main objective of the trial: 1. To compare Progression-free Survival (PFS) as assessed by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), modified to follow a maximum of 10 target...
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EU Clinical Trial 2018-002062-39 – EMA – Feb 19, 2019

A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa

Main objective of the trial: To demonstrate the efficacy of secukinumab compared to placebo with respect to HiSCR after 16 weeks of treatment.
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EU Clinical Trial 2018-003354-24 – EMA – Feb 19, 2019

Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

Main objective of the trial: The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. A...
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EU Clinical Trial 2018-002136-24 – EMA – Feb 19, 2019

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis

Main objective of the trial: Phase 2b Dose-Finding Induction • Assess the effect of TD-1473 taken daily for 8 weeks at daily doses of 20 mg, 80 mg, and 200 mg on the change in total Mayo score • Assess the effect of TD-1473 on rates of clinical remis...
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EU Clinical Trial 2018-000752-18 – EMA – Feb 19, 2019

Ajmaline provocation in asymptomatic PLN and PKP2 mutation carriers for early detection of Arrhythmogenic Cardiomyopathy

Main objective of the trial: Describe the electrocardiographic changes and areas of late myocardial activation encountered in PLN and PKP2 mutation carriers, patients and controles during ajmaline provocation . And use this information for the detect...
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EU Clinical Trial 2018-003349-41 – EMA – Feb 19, 2019

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis

Main objective of the trial: The primary efficacy objective is to evaluate the efficacy of ST-0529 in achieving clinical remission in subjects with moderately to severely active ulcerative colitis. The safety objective is to evaluate the safety and t...
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EU Clinical Trial 2018-003537-15 – EMA – Feb 18, 2019

Different dosing of Tranexamic Acid in patients undergoing elective total hip or knee arthroplasty. A randomized, controlled, double-blinded clinical trial.

Main objective of the trial: To compare the efficacy of two different dosing regimens of intravenous Tranexamic Acid during total hip or knee arthroplasty by assessing the total perioperative blood loss from start of surgery until 24 hours after end...
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EU Clinical Trial 2018-002872-42 – EMA – Feb 18, 2019

A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer (CALLA).

Main objective of the trial: To assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of Progression-Free Survival (PFS)
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EU Clinical Trial 2018-003176-13 – EMA – Feb 18, 2019

Lowering Branched-Chain Amino Acids as a New Strategy to Treat Diabetes

Main objective of the trial: Primary objective is the delta change in whole body insulin sensitivity expressed as glucose disposal rate (μmol/kg/min) upon 2 weeks of Na-PB vs. placebo treatment.
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EU Clinical Trial 2018-002623-42 – EMA – Feb 18, 2019

Vasospastic angina treatment by Endothelin Receptor Antagonism; a proof of concept study

Main objective of the trial: The primary objective of this study is to determine whether treatment with the novel ERA macitentan on top of background antianginal therapy reduces the frequency and severity of anginal complaints in patients with VSA. D...
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EU Clinical Trial 2018-004727-37 – EMA – Feb 18, 2019

A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR).

Main objective of the trial: Phase I: • To identify the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of [177Lu]-NeoB Phase IIa: • To assess the Disease Control Rate (DCR) at week 20 of [177Lu]-NeoB at the RP2D
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EU Clinical Trial 2017-002365-22 – EMA – Feb 15, 2019

Open-label, single administration, ascending dose study to explore the safety and efficacy of a gene therapy with a unilateral subretinal administration of HORA RLBP1 in patients with a retinal dystrophy harbouring biallelic mutations in the RLBP1 gene leading to a defect in CRALBP expression

Main objective of the trial: To assess the safety of a unilateral subretinal administration of HORA RLBP1
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EU Clinical Trial 2018-000399-13 – EMA – Feb 15, 2019

A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced squamous NSCLC (sqNSCLC) harbouring FGFR genetic alterations after relapse of standard therapy

Main objective of the trial: To evaluate the efficacy of erdafitinib in sqNSCLC with FGFR genetic alteration
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EU Clinical Trial 2018-002145-11 – EMA – Feb 15, 2019

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

Main objective of the trial: The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in subjects who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 mo...
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EU Clinical Trial 2018-002433-38 – EMA – Feb 15, 2019

A First-in-Human Study to Evaluate the Safety and Tolerability of QR-421a in Subjects with Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A Gene

Main objective of the trial: To evaluate the safety and tolerability of QR-421a.
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EU Clinical Trial 2018-001974-76 – EMA – Feb 15, 2019

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

Main objective of the trial: To compare the recurrence-free survival (RFS), as assessed by the investigator and confirmed by biopsy, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy
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EU Clinical Trial 2018-003460-30 – EMA – Feb 14, 2019

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)

Main objective of the trial: To find out the effectiveness of durvalumab combined with olaparib compared to durvalumab alone
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EU Clinical Trial 2018-002299-41 – EMA – Feb 14, 2019

A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis

Main objective of the trial: To explore the efficacy and safety of KY1005 on the signs of atopic dermatitis (AD) using the Eczema Area and Severity Index (EASI) and the incidence of treatment-emergent adverse events (TEAEs).
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EU Clinical Trial 2017-003619-20 – EMA – Feb 14, 2019

Long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes

Main objective of the trial: The primary objective is to assess the long-term effects of treatment with semaglutide compared to placebo, both added to standard-of-care, on diabetic retinopathy development and progression in subjects with T2D
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EU Clinical Trial 2015-005358-36 – EMA – Feb 14, 2019

I8B MC ITRO A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Main objective of the trial: To test the hypothesis that LY900014 is noninferior to Humalog on glycemic control ([NIM = 0.4% for HbA1c) in patients with T1D using CSII for 16 weeks
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EU Clinical Trial 2018-003926-10 – EMA – Feb 13, 2019

Prospective comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the initial work-up of Multiple Myeloma

Main objective of the trial: To compare FCH-PET and FDG-PET for the number of bone lesions detected and confirmed by reference test in patients with newly diagnosed MM and not yet treated
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EU Clinical Trial 2018-001461-16 – EMA – Feb 13, 2019

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies

Main objective of the trial: To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RPTD)
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EU Clinical Trial 2018-002210-12 – EMA – Feb 13, 2019

A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

Main objective of the trial: To determine the long-term safety and tolerability of lucerastat in subjects with Fabry disease
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EU Clinical Trial 2017-002154-36 – EMA – Feb 13, 2019

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled Severe Japanese Cedar Pollinosis Despite the Current Recommended Therapies

Main objective of the trial: To demonstrate the efficacy of omalizumab compared with placebo
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