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Trial record 3 of 3 for:    antibe | Canada

Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients

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ClinicalTrials.gov Identifier: NCT03978208
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
Antibe Therapeutics Inc.

Brief Summary:
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: ATB-346 low dose Other: Placebo Drug: ATB-346 mid-dose Drug: ATB-346 standard dose Phase 2

Detailed Description:

The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of once daily administration of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.A total of 360 evaluable patients are planned in this study: 250 mg (n=120); 200 mg (n=120); 150 mg (n=60); placebo (n=60).

Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Overencapsulation of study drug tablets
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Placebo Comparator
ATB-346 150 mg overencapsulated tablet taken by mouth once daily for 14 days
Drug: ATB-346 low dose
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
Other Name: Active comparator

Active Comparator: ATB-346 mid-dose
ATB-346 200 mg overencapsulated tablet taken by mouth once daily for 14 days
Drug: ATB-346 mid-dose
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
Other Name: Active comparator

Active Comparator: ATB-346 standard dose
ATB-346 250 mg overencapsulated tablet taken by mouth once daily for 14 days
Drug: ATB-346 standard dose
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
Other Name: Active comparator

Placebo Comparator: Active Comparator
Overencapsulated placebo tablet taken by mouth once daily for 14 days
Other: Placebo
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
Other Name: Non-active comparator




Primary Outcome Measures :
  1. 5-item pain intensity measure [ Time Frame: Previous 48 hours ]
    Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 50


Secondary Outcome Measures :
  1. 2-item stiffness intensity measure [ Time Frame: Previous 48 hours ]
    Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 20

  2. 17-item difficulty performing daily activities measure [ Time Frame: Previous 48 hours ]
    Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 170

  3. Measurement of whole blood cyclo-oxygenase activity [ Time Frame: After 1, 4 and 14 days of treatment dosing. ]
    Thromboxane B2 (TXB2) blood levels (pg/mL) will be measured after 1, 4 and 14 days of treatment. samples taken on days 1, 4 and 14. Decreases (measured in pg/mL) in the blood levels of thromboxane B2 are a direct measure of the effect of treatment on cyclo-oxygenase activity and the reduced production of this inflammatory mediator, i.e., thromboxane B2.

  4. Number of patients with genetic variations in the drug modifying enzyme CYP2C9 that may alter the metabolism of ATB-346 will be investigated. [ Time Frame: Samples will be retained through study completion and analyzed within 1 year of study initiation. ]
    CYP2C9 isoforms will be measured in one blood sample taken prior to study drug dosing.

  5. Number of participants with treatment-related adverse events [ Time Frame: Pre-study and days 4, 14 and 24. ]
    The safety of ATB-346 will be monitored via on study and two week post study physician and clinical laboratory assessments.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis greater than 2 years duration requiring the use of regular therapies, e.g. oral or topical anti-inflammatories, acetaminophen, topical capsaicin
  • Between the ages of 40 to 75
  • BMI ≤40
  • Patients must be unlikely to procreate or agree to the use of acceptable contraceptive regimens from first drug administration , during the study, and for at least 30 days after the last dose
  • Patients must not have used aspirin or naproxen-containing medications for 7 days prior to study entry
  • Patients must not have used any anti-inflammatory medications or acetaminophen for 5 days prior to study entry
  • Patients must show a ≥10-point increase in WOMAC Visual Analog Score between their screening visit and baseline study entry visit

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Seated and resting pulse rate less than 50 beats per minute (bpm) or more than 100 bpm at screening
  • Seated and resting blood pressure below 100/60 mmHg or higher than 140/90 mmHg at screening
  • History of significant hypersensitivity to naproxen, other non-steroidal anti-inflammatory agents, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Patients with a history of GI bleeding or ulceration
  • Patients refractory to NSAIDs
  • Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or know to potentiate or predispose patients to undesired effects
  • Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease as determined by the investigator
  • Suicidal tendency, history of/or disposition to seizures, state of confusion
  • History of hepatic disease
  • Maintenance therapy with any drug, including gastroprotective agents such as proton pump inhibitors, H2 receptor antagonists, sucralfate, etc., or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the previous 30 days before Day 1 of this study
  • Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John`s Wort) in the previous 30 days before Day 1 of this study
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive H. Pylori Urea Breathe Test
  • Positive urine screening of alcohol and/or drugs of abuse at the screening visit
  • Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAg) or anti-Hepatitis C Virus (HCV) tests
  • Females who are pregnant according to a positive serum pregnancy test
  • Patients who took an Investigational Product (in another clinical trial) in the previous 30 days before Day 1 of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978208


Contacts
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Contact: David Vaughan, PhD 905 831 9290 david.vaughan@antibethera.com

Locations
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Canada, Ontario
Milestone Research Inc. Recruiting
London, Ontario, Canada, N5W 6A2
Contact: Peter Dzongowski, MD         
Canadian Phase Onward Inc. Recruiting
Toronto, Ontario, Canada, M3J 0K2
Contact: Lew Pliamm, MD         
LMC Clinical Research Inc Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: Azhar Toma, MD         
Devonshire Clinical Research Inc. Recruiting
Woodstock, Ontario, Canada, N4S 5P5
Contact: Kenneth Heaton, MD         
Sponsors and Collaborators
Antibe Therapeutics Inc.
Veristat, Inc.
Investigators
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Study Director: Deepen Patel, MD Veristat

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Responsible Party: Antibe Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03978208     History of Changes
Other Study ID Numbers: ATB-346-P2B-DRF
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antibe Therapeutics Inc.:
Knee
WOMAC
NSAID
Pain
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action