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 (...
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
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...
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...
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...
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.
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...
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...
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
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...
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...
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...
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.
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
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 [...
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...
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.
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...
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...
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.
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...
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...
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...
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.
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...
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...
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...
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...
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...
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)
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...
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
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
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...
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
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
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).
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
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