Clinical trials: Phase 2
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Duchenne Muscular Dystrophy
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
- Trial name
- NCT05693142
- Testing
- RGX-202
- Where
- 23 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- REGENXBIO Inc.
Biotinidase Deficiency
Study of ORL-1B in Patients With Biotinidase Deficiency
An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.
- Trial name
- NCT03269045
- Testing
- ORL-1B
- Volunteers
- 20 people
- Sponsor
- Orpha Labs
Retinitis Pigmentosa (RP)
Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).
- Trial name
- PRISM (NCT07282457)
- Testing
- ZM-02 (low dose), ZM-02 (high dose), ZM-02 (selected dose)
- Volunteers
- 21 people
- Sponsor
- Zhongmou Therapeutics
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
HIV/AIDS
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune…
- Trial name
- NCT02291809
- Testing
- REMUNE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Immune Response BioPharma, Inc.
Pneumonia, Pneumococcal
Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.
- Trial name
- NCT04278248
- Testing
- 23-Valent Pneumococcal Polysaccharide Vaccine
- Where
- China
- Volunteers
- 1,940 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Respiratory Syncytial Virus Infections
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
- Trial name
- NCT00192478
- Testing
- Medi-524
- Where
- 3 sites in Argentina, Chile
- Volunteers
- 217 people
- Sponsor
- MedImmune LLC
Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
- Trial name
- NCT00866047
- Testing
- brentuximab vedotin
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 58 people
- Sponsor
- Seagen Inc.
Infections, Meningococcal
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months.
- Trial name
- NCT01939158
- Testing
- Meningococcal vaccine GSK134612, Prevenar 13™
- Where
- 51 sites in Australia, Canada and 4 more
- Volunteers
- 803 people, healthy volunteers welcome
- Sponsor
- Pfizer
Sickle-Cell Disease
Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease…
- Trial name
- NCT02515838
- Testing
- Sevuparin
- Where
- 20 sites in Bahrain, Jamaica and 5 more
- Volunteers
- 147 people
- Sponsor
- Modus Therapeutics AB
Autistic Disorder
Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism.
- Trial name
- NCT03919721
- Testing
- Applied Behavioral Analysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Experiad LLC
Infections, Rotavirus
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan.
- Trial name
- NCT03954743
- Testing
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 1,351 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Sickle Cell Disease
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke
The study will test a new medicine, etavopivat, for sickle cell disease and see if it is safe and help-ful for participants with sickle cell disease who are at an increased risk of stroke.
- Trial name
- HIBISCUS 3 (NCT05953584)
- Testing
- Etavopivat, Hydroxyurea
- Where
- 9 sites in India, Nigeria and 1 more
- Volunteers
- 27 people
- Sponsor
- Forma Therapeutics, Inc.
Acne Vulgaris
Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
The purpose of this study is to evaluate the superiority in efficacy and assess safety and tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active components or the vehicle for the treatment of…
- Trial name
- NCT02661958
- Testing
- S6G5T-3, S6G5T-1, S6G5T-5
- Where
- 34 sites in United States
- Volunteers
- 726 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Alzheimer's Disease
AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease
This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102.
- Trial name
- NCT00606476
- Testing
- Bapineuzumab (AAB-001)
- Where
- 29 sites in United States
- Volunteers
- 194 people
- Sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Dengue Fever, Dengue Hemorrhagic Fever
Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age
The aim of the study was to assess the immune response and the safety of different vaccination schedules of CYD dengue vaccine. The primary objectives of the study were: To demonstrate the non-inferiority of the immune response…
- Trial name
- NCT02628444
- Testing
- CYD Dengue Vaccine
- Where
- 6 sites in Colombia, Philippines
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
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