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SUNY Downstate Clinical Trial Office provides a wide spectrum of research opportunities for the promotion of innovative and quality healthcare within the Brooklyn community. These services include numerous clinical trials that explore new medications, treatments and therapeutic devices that may help our patients dealing with a wide variety of diseases.

What Is a Clinical Trial?

A clinical trial is a thorough and carefully controlled evaluation of a new medical test or treatment.

A clinical trial is a health-related research study in human beings that follows a pre-defined protocol. Interventional studies aim to answer specific questions about new therapies or new ways of using known treatments, while observational studies are those in which patients are observed and their outcomes are measured by the investigators. Carefully conducted clinical trials are the safest and most efficient way to identify treatments that work in people.

Before a clinical trial begins, the treatment must show that it has potential benefit. It also must meet rigorous government standards and scientific requirements for safety and have acceptable side effects before the study can be done on humans.

Ultimately, the only way to determine the true benefit and safety of a treatment is to test it on people with the disease or condition for which the treatment was developed. Clinical trials are one of the steps in determining how effective a drug or treatment is in improving the outcome a disease or medical condition.

Examples of What a Clinical Trial May Investigate:

  • New treatments (drug or devices)
  • New ways to use existing treatments
  • New screening and diagnostic techniques
  • Healthy participants only
  • Participants with specific illnesses/conditions

 

Why Do We Have Clinical Trials?

Due to improvements in medical treatments, many more patients are surviving serious illnesses that they might not have years ago. These improvements were accomplished through research, both in the laboratory and in the clinical setting. However, there are still many questions to be answered about treatments for patients and the care they receive. Finding answers to these questions is why research is an essential part of SUNY Downstate.

 

Types of Clinical Trials

There are many different types of clinical trials and many ways patients and their families can participate. A clinical trial can:

  • Compare two medications or treatments to learn which works better for patients
  • Examine how well a medication works and what side effects may occur
  • Observe the general condition of the patient to learn about a specific disease process or group of symptoms, and how they affect patients
  • Test new medical devices

Clinical Trials Open to Enrollment

Please review the following disciplines for available clinical trials. If interested in a trial, contact information is provided.

Treatment of Social Communication and Language Deficits with Leucovorin for Young Children with ASD

Study to treat young children with ASD with Leucovorin - Full Text View - ClinicalTrials.gov (NCT # 04060030)

Harris Huberman, MD
Coordinator: (718) 270-4657

Early Treatment of Language Impairment in Young Children with Autism Spectrum Disorder with Levoleucovorin

Study of language impairment in Young Children - Full Text View - ClinicalTrials.Gov (NCT # 04060017)

Harris Huberman, MD
Coordinator: (718) 270-4657

A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel D 1 Antibodies During Natural Cat Exposure in the Home

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat - Full Text View - ClinicalTrials.gov (NCT # 04981717)

Rauno Joks, MD
Coordinator: (718) 270-6595

(RD.06.SPR.118126) A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (aged 2 to 11 years) with Moderate-to-Severe Atopic Dermatitis

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis - Full Text View - ClinicalTrials.gov (NCT # 04921345)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(ARQ-151-312) A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects with Atopic Dermatitis

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) - Full Text View - ClinicalTrials.gov (NCT # 04773600)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(ARQ-151-313) A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis

Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis - Full Text View - ClinicalTrials.gov (NCT # 04804605)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(ARQ-151-315) A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects with Atopic Dermatitis

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED) - Full Text View - ClinicalTrials.gov (NCT # 04845620)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(DMVT-505-3102) A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102) - Full Text View - ClinicalTrials.gov (NCT # 05032859)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(DMVT-505-3103) An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream 1% in Subjects with Atopic Dermatitis

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis - Full Text View - ClinicalTrials.gov (NCT # 05142774)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

(INCB 18424-214) A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo

A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA) - Full Text View - ClinicalTrials.gov (NCT # 04896385)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

A pragmatic trial of home versus office based narrow band ultraviolet B phototherapy for the treatment of psoriasis

Light Treatment Effectiveness (LITE) Study - Full Text View - ClinicalTrials.gov (NCT # 03726489)

Jeannette Jakus, MD
Coordinator: (718) 270-1229

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus

Randomized Therapy In Status Epilepticus - Full Text View - ClinicalTrials.gov (NCT # 04391569)

Arthur Grant, MD
Coordinator: (718) 270-2959

Leveraging Family-Based Assets for Black MSM in House Ball Communities

Leveraging Family-Based Assets for Black MSM In House Ball Communities - Full Text View - ClinicalTrials.gov (NCT # 05071378)

Jeffrey Birnbaum, MD
Coordinator: (718) 613-8453

A SMART Approach to Treating Tobacco Use Disorder in Persons Living with HIV

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV - Full Text View - ClinicalTrials.gov (NCT # 04490057)

Jessica Yager, MD
Coordinator: (718) 613-8641

 

Supporting Treatment Adherence for Resilience and Thriving (START)

Sabina Hirshfield, MD
Coordinator: (917) 282-4620

A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Safety and Efficacy of ANG-3070 in Patients with Primary Glomerular Disease and Persistent Proteinuria

Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease - Full Text View - ClinicalTrials.gov (NCT # 04939116)

Subodh Saggi, MD
Coordinator: (718) 270-1148

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 years) with Type 2 Diabetes Mellitus

A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus - Full Text View - ClinicalTrials.gov (NCT # 03170518)

Vatcharapan Umpaichitra, MD
Coordinator: (718) 270-4657; (718) 613-8605

A Phase III, Randomize, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus (CA42750)

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus - Full Text View - ClinicalTrials.gov (NCT # 04963296)

Ellen Ginzler, MD
Coordinator: (718) 270-3736

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis (CA41705)

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis - Full Text View - ClinicalTrials.gov (NCT # 04221477)

Ellen Ginzler, MD
Coordinator: (718) 270-3736; (718) 270-1662