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A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the
Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe
Rheumatoid Arthritis

1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (eow) intravenously (IV) in subjects with moderately to severely active RA on background MTX.2. To compare clinical efficacy of ABBV-3373 with adalimumab…

Single-stage bone-anchored hearing implant surgery in the pediatric population using the BHX implant

To compare implant loss between single-stage BAHI surgery (test group) and two-stage BAHI surgery (control group) in children. Furthermore, to compare soft tissue status, time to loading and duration of surgery between groups.

How should we treat a patient with a distal radius fracture after closed reduction? A cluster RCT*

To evaluate the cost-effectiveness of treatment with a circumferential cast compared to treatment with a splint, in patients with a reduced distal radius fracture. The hypothesis is that reduced distal radius fractures treated with a circumferential…

MERLIN: hoMEcare aRm rehabiLItatioN

The goal of this study is to test the effectiveness of using the ArmAssist and Antari Homecare platform at home on upper extremity function in chronic stroke patients.Secundairy objectives are:- To evaluate the user-friendliness of the ArmAssist and…

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2)

Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…

Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP)

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 (with each regimen consisting of a loading and a separate maintenance subcutaneous dose) compared to placebo. The target dose(s) will be estimated from the model…

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in patients with PPMS, including patients later in their disease course.

An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjects

Primary objective:* To determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted conditions versus a capsule formulation given under fasted conditions.Secondary objectives:* To determine the relative…

A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma

Primary objective: To evaluate the efficacy of JNJ-68284528 (Phase 2)Secondary objectives:# To characterize the safety of JNJ-68284528 (Phase 2)# To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528# To assess the immunogenicity…

Early implicit promotion of vitality in breast cancer patients during neo-adjuvant treatment.

The objective of this study is to test the CBM eHealth app, with regard to the influence of the app on implicit fatigue self-concept and on explicitly experienced fatigue and vitality, both immediately after finishing the two-weekly training.…

A single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 4-way cross-over study to assess next-day driving performance following single and multiple evening administrations of ACT-541468 in middle-aged and elderly subjects.

Primary objective- To evaluate the effects of ACT-541468 on objective simulated driving performance, i.e., the standard deviation of the lateral position (SDLP), after single- and multiple dose administrations (i.e., on Day 1 and Day 4) in the…

A Randomized, Double-Blind, Vehicle-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topically Applied INM-755 Cream in Healthy Volunteers

Part 1Primary ObjectiveTo evaluate the local and systemic safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 days on healthy skin of healthy volunteersSecondary ObjectiveTo assess the local and…

Feasibility and Reliability of the Muscle Sound® Technique in a Morbidly Obesity Population

Evaluation of the feasibility and reproducibility of Muscle Sound® in a morbid obese population.

The effects of a nutritional supplement on sleep efficiency, sleep duration and stress, and the effect of audio intervention on deep sleep, in apparently healthy adults with sleep disturbances: a randomized controlled cross-over study

The primary objective is to increase sleep quality, and to assess the effect of audio intervention (SmartSleep; Philips Respironics, Murrysville, PA) on deep sleep. Secondary objectives are to improve sleep efficiency, sleep duration, and to reduce…

An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy

The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patientswith active PNH who are treatment-naive to complement inhibitor therapy or have not recently received…

ECG Belt for CRT Response

The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling..

A phase 1, 4-period, crossover, open-label study in healthy volunteers to assess the effect of different types of food on a single-dose of JNJ-64417184 administered as tablets.

The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 is absorbed, distributed, metabolized and eliminated from the body. The pharmacokinetics of JNJ-64417184 when it is administered in the morning following the…

Optimizing timing of glucocorticoid treatment in children with congenital adrenal hyperplasia

To study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.

An open-label, mass balance study to investigate the absorption, metabolism and excretion of [14C]-EYP001a after a single oral dose to healthy male subjects

Primary objectives:To determine the ratio of parent drug to metabolites in the circulation following administration of a single oral dose of 400 mg [14C]-EYP001a containing 100 µCi radioactivity.Profiling of EYP001a metabolites in blood, urine and…

A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects
Who Are Homozygous for the F508del Mutation

In Part 1 of the study, a fixed dose of ABBV-3067 (potentiator) will be co-administered with ABBV-2222 (corrector) in a dose range-finding manner to enable a dose selection for ABBV-2222 for Part 2 and future combination studies. In addition, ABBV-…