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A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

This study has been transitioned to CTIS with ID 2023-506004-93-00 check the CTIS register for the current data. Main: - To evaluate the effect of efavaleukin alfa on induction of clinical remissionSecondary: - To evaluate the effect of efavaleukin…

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…

Randomised, double-blind, placebo-controlled and parallel group
trial to investigate the effects of two doses (up-titration to a fixed
dose regimen) of oral BI 685509 on portal hypertension after 24
weeks treatment in patients with clinically significant portal
hypertension (CSPH) in compensated cirrhosis

The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…

A Study to Assess the Effects of the Endothelin Receptor Antagonist Zibotentan and the SGLT2 Inhibitor Dapagliflozin in Patients elevated Albuminuria: a Randomized Double Blind Cross-Over Trial

This study investigates how well the combination of the two drugs, zibotentan and dapagliflozin, works for the treatment of chronic kidney disease in patients. We compare the effect of zibotentan and dapagliflozin with the effect of a placebo. The…

A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients with Recurrent/Metastatic HPV16 Cervical Cancer who have Experienced Disease Progression after First Line Chemotherapy

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).The secondary objectives of the study are:• To characterize the…

EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

This study has been transitioned to CTIS with ID 2023-508530-34-00 check the CTIS register for the current data. Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with…

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

This study has been transitioned to CTIS with ID 2024-511793-71-00 check the CTIS register for the current data. Phase 1Primary Objective• To determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with…

A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf*)

The primary objective of the trial is to assess a non-flat dose-response curve and to evaluate the dose-response relationship for 3 oral dose regimens of BI 1291583 versus placebo, on the primary endpoint, time to first pulmonary exacerbation up to…

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

This study has been transitioned to CTIS with ID 2024-513854-31-00 check the CTIS register for the current data. To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.

A Phase 2 study to assess the efficacy and safety of 2 dosage regimens of oral fidrisertib (IPN60130) for the treatment of fibrodysplasia ossificans progressiva in male and female paediatric and adult participants

This study has been transitioned to CTIS with ID 2024-511469-13-00 check the CTIS register for the current data. Main objective:• Evaluate the efficacy of IPN60130 monotherapy compared with placebo recipients in inhibiting new HO volume in adult and…

Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection - a controlled human infection study

Study A: Validation of productive infection of RSV CHIMStudy B: Effectiveness and immunogenicity of local administration of palivizumab on prevention of experimental RSV infection

A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers

Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

• To assess the efficacy of rozanolixizumab as measured by seizure freedom• To assess the efficacy of ozanolixizumab as measured by change in cognitive function• To assess the efficacy of ozanolixizumab as measured by use of rescue medication• To…

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis

This study has been transitioned to CTIS with ID 2024-514617-35-00 check the CTIS register for the current data. Primary Objective1. To evaluate the efficacy of IMU-838 versus placebo as measured by quantitative magnetic resonance imaging (MRI)…

A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-04)

This study has been transitioned to CTIS with ID 2023-508342-17-00 check the CTIS register for the current data. Primary Objective• To assess the effect of ALX148 + pembrolizumab + 5FU + platinum on 12-month overall survival (OS) rate and objective…

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab
in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of
Treatment (DeLLphi-301)

Primary (Parts 1 and 2)• To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab Primary (Part 3)Evaluate safety of reduced mandatory monitoring…

A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of SAR445088 (previously BIVV020) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)

This study has been transitioned to CTIS with ID 2024-512345-16-00 check the CTIS register for the current data. The purpose of this BIVV020 Phase 2 study is to determine the preliminary efficacy, safety, and tolerability of BIVV020 in three CIDP…

A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren*s Syndrome

The primary objective of this study is to evaluate the safety and tolerability of iscalimab at two dose levels (600 mg and 300 mg) in patients withSjögren*s Syndrome, who participated in the TWINSS core study,CCFZ533B2201.Secondary…

An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor of the Knee

Obtain safety and efficacy data for the investigational drug AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT)

HYPo-fractionated Radiotherapy of Lymph Node Metastases guided by NanO-MRI in Prostate Cancer Patients: A Pilot Study (HYPNO-study)

To evaluate the feasibility and efficacy of MR-guided stereotactic body radiotherapy (SBRT) to nano-MRI detected regional lymph node metastases in patients with biochemical recurrent prostate cancer after radical prostatectomy.