Clinical trials: Step
Rheumatoid Arthritis, Ankylosing Spondylitis
Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis
- Trial name
- VALUE (NCT02750800)
- Testing
- Adalimumab, AbbVie Care 2.0
- Volunteers
- 427 people
- Sponsor
- AbbVie
Severe Eosinophilic Asthma
STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to…
- Trial name
- STEP (NCT06465485)
- Testing
- Benralizumab
- Where
- 74 sites in China
- Volunteers
- 504 people
- Sponsor
- AstraZeneca
Multiple Myeloma
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that…
- Trial name
- MagnetisMM-9 (NCT05014412)
- Testing
- Elranatamab
- Where
- 50 sites in United States, Japan and 2 more
- Volunteers
- 86 people
- Sponsor
- Pfizer
Autoimmune
Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.
This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to…
- Trial name
- NCT07291323
- Testing
- JANX011
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Janux Therapeutics
Systemic Lupus Erythematosus, SLE
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
- Trial name
- NCT06335979
- Testing
- PIT565
- Where
- 11 sites in China, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Acromegaly
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical…
- Trial name
- HOSCAR (NCT01278342)
- Testing
- Sandostatin LAR, pegvisomant, cabergoline
- Where
- 20 sites in France, Italy and 3 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers
Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
- Trial name
- NCT02257008
- Testing
- BILR 355 BS, Grapefruit juice, Nelfinavir
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Overweight, Obesity
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy"…
- Trial name
- STEP 6 (NCT03811574)
- Testing
- Semaglutide
- Where
- 28 sites in Japan, South Korea
- Volunteers
- 401 people
- Sponsor
- Novo Nordisk A/S
Vulvovaginal Atrophy
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections.
- Trial name
- SYLIVA (NCT04219722)
- Testing
- Injection of DESIRIAL®
- Where
- 14 sites in Belgium, France
- Volunteers
- 121 people
- Sponsor
- Laboratoires Vivacy
Meningococcal Immunization
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®.
- Trial name
- NCT06165276
- Testing
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T)., Meningococcal Group C-CRM197 Conjugate Vaccine
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Allergic Rhinitis, Sinusitis
Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)
This study aims to evaluate the effectiveness of digital tools in managing allergic rhinitis (AR) in primary care settings. AR is a common condition that affects many people's quality of life.
- Trial name
- DMAR (NCT06603935)
- Testing
- QHSLab Digital Tools (AME and ARIS)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- QHSLab, Inc.
Chronic Pain, Osteoarthritis
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are…
- Trial name
- NCT00983073
- Testing
- Tapentadol
- Where
- 24 sites in France, Germany and 3 more
- Volunteers
- 224 people
- Sponsor
- Grünenthal GmbH
Pulmonary Disease, Chronic Obstructive
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational…
- Trial name
- NCT02619357
- Testing
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Uterine Fibroids
A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of…
- Trial name
- NCT01140555
- Testing
- GYNECARE GYNOCCLUDE™
- Where
- 4 sites in Austria, Germany and 2 more
- Volunteers
- 2 people
- Sponsor
- Ethicon, Inc.
Postmenopausal Women With Primary Osteoporosis
STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured…
- Trial name
- NCT00583518
- Testing
- Parathyroid hormone (PTH)
- Where
- Denmark
- Volunteers
- 129 people
- Sponsor
- Nycomed
Psoriasis Vulgaris
Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects.
- Trial name
- NCT03231124
- Testing
- LEO 32731
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
Poliomyelitis
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
The purpose of this study is to select the optimal antigen dosage of the three Sabin poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent Sabin-based inactivated poliomyelitis vaccine…
- Trial name
- NCT03092791
- Testing
- Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV), Reference IPV
- Where
- 4 sites in Panama
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatitis B Infection
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT03519113
- Testing
- GC1102 80,000 IU, GC1102 100,000 IU, I.V HBIG
- Where
- South Korea
- Volunteers
- 186 people
- Sponsor
- Green Cross Corporation
Advanced Cancer
A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced Cancer
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.
- Trial name
- NCT02432612
- Testing
- Sativex
- Sponsor
- GW Pharmaceuticals Ltd
Anovulation
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females
- Trial name
- Compass (NCT01923194)
- Testing
- Highly Purified Urofollitropin, Recombinant Human Follitropin Alfa
- Where
- 12 sites in China
- Volunteers
- 215 people
- Sponsor
- Ferring Pharmaceuticals