Clinical Research

Furthering science, research & medical developments.

Florida Medical Clinic is proud to make a difference by conducting innovative clinical trials to further clinical advancement. Numerous clinical research studies are conducted on an ongoing basis to help further science, research and medical development.

New and exceptional medications waiting for FDA approval are tested in our Clinical Research Department. Nationwide patient results are monitored and evaluated by the FDA in an effort to constantly improve medical treatments. The study length varies according to the test criteria.

Your physician can advise you about your eligibility for clinical research. Medical care, medications, and possible compensation are available to qualified patients who volunteer for a clinical trial.

Contact Us

If you would like additional information on any study listed, please contact:

William D. Johnston RN CCRC
813.780.8368
wjohnston@floridamedicalclinic.com

Our Current Clinical Trials


Study Title:

A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis


Protocol Name: AURORA
Protocol Number: 3152-301-002

Description: The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1 will continue into Part 2 and additional subjects will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.

Eligibility: 18 Years to 75 Years

Inclusion Criteria:

  1. Male and female subjects aged between 18-75 years
  2. Ability to understand and sign a written informed consent form (ICF)
  3. Histological evidence of NASH based on central reading of the Screening biopsy
  4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
  5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating hormone (FSH) ≥ 30 mU/mL at Screening.

Exclusion Criteria:

  1. Inability to undergo a liver biopsy
  2. Hepatitis B surface antigen (HBsAg) positive
  3. Hepatitis C antibody (HCVAb) positive
  4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
  5. Prior or planned liver transplantation
  6. Other known causes of chronic liver disease
  7. History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
  8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
  9. AST > 200 IU/L in males and females at Screening
  10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening
  11. HbA1c > 10% at Screening
  12. Serum albumin < 3.5 g/dL
  13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
  14. Platelet count < 100,000/mm3
  15. Total bilirubin > 1.5 mg/dL
  16. International normalized ratio (INR) > 1.3
  17. Model of end stage liver disease (MELD) score > 12
  18. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
  19. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
  20. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
  21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
  22. Females who are pregnant or breastfeeding
  23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents
  24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the Screening liver biopsy

Start Date: April 20, 2017

Projected End Date: September 16, 2020

ClinicalTrials.gov Identifier: NCT03028740

Study Web Address for Potential Patients: https://www.aurorafornash.com

 


Study Title

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis


Protocol Name: Regenerate
Protocol Number: 747-303

Description: The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Eligibility: 18 Years to 85 Years

Inclusion Criteria:

  1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
  3. Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:
    Obesity (BMI ≥30 kg/m2)
    Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
    ALT >1.5× upper limit of normal (ULN).
  4. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
  5. Stable body weight.

Exclusion Criteria:

  1. Model for End-stage Liver Disease (MELD) score >12
  2. ALT ≥10× ULN
  3. HbA1c >9.5%
  4. Total bilirubin >1.5 mg/dL
  5. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
  6. History of liver transplant, or current placement on a liver transplant list
  7. Current or history of significant alcohol consumption
  8. Prior or planned ileal resection, or prior or planned bariatric surgery
  9. Histological presence of cirrhosis
  10. History of biliary diversion
  11. Known positivity for human immunodeficiency virus infection.
  12. Acute cholecystitis or acute biliary obstruction.
  13. BMI >45 kg/m2

Start Date: September 2015

Projected End Date: October 2022

ClinicalTrials.gov Identifier: NCT02548351

Study Web Address for Potential Patients: https://nash-study.com/the-regenerate-study


Study Title

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn’s Disease


Protocol Name: Diversity 1
Protocol Number: GS-US-419-3895

Description: The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn’s disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

Eligibility: 18 Years to 75 Years

Inclusion Criteria:

  1. Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
  2. Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
  3. Moderately to severely active CD

Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Exclusion Criteria:

  1. Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae, short bowel syndrome, etc.
  2. Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  3. Active tuberculosis (TB) or history of latent TB that has not been treated
  4. Use of any prohibited concomitant medications as described in the study protocol

Start Date: September 26, 2016

Projected End Date: Dec 2019

ClinicalTrials.gov Identifier: GS-US-419-3895

Study Web Address for Potential Patients: https://www.myibdstudy.com


Study Title

This is a phase 2 study to evaluate safety and efficacy of ABBV-105 and ABBV-599 (ABBV-105 plus upadacitinib) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.


Protocol Name: N/A
Protocol Number: M16-063

Description: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs

Eligibility: 18 Years and older

Inclusion Criteria:

  1. Diagnosis of RA for >=3 months based on the 2010 ACR/EULAR classification criteria for RA.
  2. Participant meets the following minimum disease activity criteria:
    >=6 swollen joints (based on 66 joint counts) and >=6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
    hsCRP >=3 mg/L (central lab) at Screening Visit.
  3. Participants must have been treated for >=3 months with >=1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.
  4. Participants must have been receiving csDMARD therapy >=3 months and on a stable dose for >=4 weeks prior to the first dose of study drug.
  5. Participants must have discontinued all bDMARDs prior to the first dose of study drug.

Exclusion Criteria:

  1. Participant have prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).

Start Date: October 8, 2018

Projected End Date: November 17, 2019

ClinicalTrials.gov Identifier: NCT03682705

Study Web Address for Potential Patients: N/A


Study Title

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis


Protocol Name: MANTA
Protocol Number: GS-US-418-4279

Description: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis (MANTA)

Eligibility: 25 Years to 55 Years

Inclusion Criteria:

  1. Male participants who are between the ages of 25 and 55 (inclusive) on the day of signing informed consent
  2. Documented diagnosis of ulcerative colitis (UC) of at least 4 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC
  3. Have moderately to severely active UC

Exclusion Criteria:

  1. Previously documented problems with male reproductive health
  2. Prior diagnosis of male infertility
  3. Presence of Crohn’s disease (CD), indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega-colon
  4. Active tuberculosis (TB) or history of latent TB that has not been treated
  5. Use of concomitant prohibited medications as outlined by protocol

Start Date: July 11, 2017

Projected End Date: January 2021

ClinicalTrials.gov Identifier: NCT03201445

Study Web Address for Potential Patients: https://www.myibdstudy.com

 


Study Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis


Protocol Name: RESOLVE-IT
Protocol Number: GFT505-315-1

Description: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

Eligibility: 18 Years to 75 Years

Inclusion Criteria:

  1. Males or females aged from 18 to 75 years inclusive at first screening visit.
  2. Must provide signed written informed consent and agree to comply with the study protocol.
  3. BMI ≤45 kg/m².
  4. Females participating in the study must either not be of childbearing potential (hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of menses for at least 12 months due to ovarian failure) or using efficient double contraception: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device, or other mechanical contraception method + condom or diaphragm or spermicide for the full duration of the study and for 1 month after the end of treatment.
  5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
  6. NAS score ≥4.
  7. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
  8. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
  9. No change in antidiabetic therapy within 6 months prior to liver biopsy

Exclusion Criteria:

  1. Known heart failure (Grade I to IV of New York Heart Association classification).
  2. History of efficient bariatric surgery within 5 years prior to screening.
  3. Uncontrolled hypertension
  4. Type 1 diabetes patients.
  5. Patients with decompensated diabetes (HbA1c>9%).
  6. Patients with a history of clinically significant acute cardiac event within 6 months prior to screening
  7. Weight loss of more than 5% within 6 months prior to randomization
  8. Compensated and decompensated cirrhosis
  9. Current or recent history (<5 years) of significant alcohol consumption
  10. Pregnant or lactating females or females planning to become pregnant during the study period.
  11. Other well documented causes of chronic liver disease according to standard diagnostic procedures
  12. Patients with previous exposure to Elafibranor
  13. Prohibited concomitant medication
  14. Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
  15. Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
  16. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Start Date: March 2016

Projected End Date: December 2021

ClinicalTrials.gov Identifier: NCT02704403

Study Web Address for Potential Patients: http://www.resolve-it-nash-study.com

 


Study Title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis


Protocol Name: REVERSE
Protocol Number: 747-304

Description: The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Eligibility: 18 Years and older

Inclusion Criteria:

  1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

Exclusion Criteria:

  1. Current or past history of hepatic decompensation such as clinically significant ascites, hepatic encephalopathy (HE), or variceal bleeding
  2. Current or past history of CP score ≥7 points
  3. Model for End-stage Liver Disease (MELD) score > 12
  4. ALT ≥ 5 X ULN
  5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method
  6. Hemoglobin A1c ≥ 9.5 %
  7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
  8. History of liver transplant, or current placement on a liver transplant list

Start Date: August 30, 2017

Projected End Date: July 2020

ClinicalTrials.gov Identifier: NCT03439254

Study Web Address for Potential Patients: https://nash-study.com


Study Title

A Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)


Protocol Name: ASLeap
Protocol Number: CAIN457FUS06

Description: Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis (ASLeap)

Eligibility: 18 Years and older

Inclusion Criteria:

  1. Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent
  2. Male or non-pregnant, non-lactating female patients at least 18 years of age
  3. Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
  4. Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline
  5. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
  6. Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline
  7. Patients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications
  8. Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit
  9. Patients who have been on a tumor necrosis factor alpha (TNFα) inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of an anti-TNFα agent

Exclusion Criteria:

  1. Total ankylosis of the spine
  2. Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.
  3. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
  4. Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
  5. Previous exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFα
  6. Patients who have taken more than one anti-TNFα agent
  7. Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
  8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline
  9. Previous treatment with any cell-depleting therapies
  10. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)

Start Date: March 13, 2018

Projected End Date: August 31, 2020

ClinicalTrials.gov Identifier: NCT03350815

Study Web Address for Potential Patients: https://www.asleap.com/

 


Study Title

US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice


Protocol Name: OPUS
Protocol Number: AC-055-503

Description: OPsumit USers Registry (OPUS)

Eligibility: Child, Adult, Older Adult

Inclusion Criteria:

  1. Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
  2. Signed ICF

Exclusion Criteria:

  1. Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.
  2. Patients enrolled in any ongoing clinical trials

Start Date: April 30, 2014

Projected End Date: June 30, 2019

ClinicalTrials.gov Identifier: NCT02126943

Study Web Address for Potential Patients: http://opus-study.com/


Study Title

A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)


Protocol Name: Ri-CoDIFy
Protocol Number: SMT19969/C004

Description: Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)

Eligibility: 18 Years and older

Inclusion Criteria:

  1. At least 18 years of age, at the time of signing the informed consent.
  2. Signs and symptoms of CDI including diarrhea such that in the Investigator’s opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 Unformed Bowel Movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
  3. The presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test, produced within 72 hours prior to randomization.
  4. Male or Female
    • Male must agree to use contraception as detailed in the protocol during the treatment period and for at least 5 days after study treatment and refrain from donating sperm during this period.
    • Female patient is eligible to participate if she is not pregnant, not breastfeeding, and either:

Not a woman of childbearing potential (WOCBP). A WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 5 days after study treatment.

  1. Documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]).

Exclusion Criteria:

  1. More than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months.
  2. A history of chronic diarrheal disease including inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  3. Positive diagnostic test for other gastro intestinal (GI) pathogens within 2 weeks of randomization.
  4. Major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (except appendectomy). Presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
  5. Life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
  6. Current history of significantly compromised immune system e.g.:
    1. HIV positive with a CD4<200 cells/mm3 within 6 months of randomization.
    2. Severe neutropenia with neutrophil count < 500 cells/mL.
    3. Concurrent immunosuppressive therapy for recent (within previous 6 months) or anticipated solid organ transplant or bone marrow transplant.
    4. Concurrent chemotherapy, radiotherapy or biologic for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study.
  7. More than one day (24 hours) of dosing of antimicrobial treatment active against CDI for the current episode of CDI prior to randomization.
  8. Prior or current use of anti-toxin antibodies including bezlotoxumab.
  9. Unable to discontinue products used to affect bowel movement or disease progression.
  10. Involved in a clinical trial and received an IMP for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the IMP was for CDI.
  11. Received an investigational vaccine against C.difficile.
  12. Patients that the Investigator feels are inappropriate for the study for any other reason e.g. have any conditions that would make the patient unsuitable for inclusion, patients not likely to complete the study for whatever reason, known hypersensitivity or intolerance to study IMPs, patients unwilling or unable to comply with protocol requirements

Start Date: March 2019

Projected End Date: March 2021

ClinicalTrials.gov Identifier: NCT03595553

Study Web Address for Potential Patients: N/A