- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286789
Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs
October 15, 2021 updated by: Oryn Therapeutics, LLC
A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs
This is a randomized, vehicle controlled, double-blind, repeat dose comparative study in patients with rheumatoid arthritis (RA) under management with DMARDs and with persistent disease activity.
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of 6 weekly repeat doses of ORTD-1.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- Keck School of Medicine of USC Division of Rheumatology
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Tustin, California, United States, 92780
- Orange County Research Center
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Florida
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Miami, Florida, United States, 33147
- Advanced Pharma CR, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥18 years of age or older, males or females.
- Diagnosed rheumatoid arthritis per the American Rheumatism Association 1987 classification criteria of at least 6 months duration.
Disease activity defined as:
- erythrocyte sedimentation rate (ESR) > 24 mm or serum C-reactive protein level ≥ 1.2 times (X) the upper limit of normal (ULN), and
- DAS28-CRP score ≥ 2.6 and < 5.1
- Current regimen of DMARDs that may include methotrexate, sulfasalazine, hydroxychloroquine, leflunomide and/or azathioprine, alone or in combination.
- No change in DMARD dose(s) within 4 weeks prior to Screening.
- May be receiving a stable regimen (of at least 4 weeks duration) of concomitant NSAIDs.
Women of child-bearing potential (WOCBP), defined as a sexually mature woman not surgically sterilized, or not post-menopausal for at least 12 consecutive months. Female subjects must:
- Not be lactating; not be pregnant upon enrollment.
- Agree to use highly effective methods of birth control throughout the study. Highly effective methods of contraception include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation by oral, intravaginal, or transdermal administration; progestogen-only hormonal contraception associated with inhibition of ovulation by oral, injectable, or implantable administration; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; partner vasectomy; or total abstinence (only if total abstinence is an established method and lifestyle of the subject).
- Patients already using hormonal contraception at the time of screening will be eligible but will not initiate hormonal contraception in order to participate in the study.
- Agree to use highly effective methods of birth control for at least 6 months after the last dose of investigational product.
- Male subjects must refrain from donating sperm or fathering a child during the study.
- Male subjects must use barrier contraception throughout the course of the study.
- Signed and dated informed consent.
Exclusion Criteria:
- Prior therapy with any biologic therapeutic within 3 months prior to enrollment, or in the case of Rituxan (rituximab), this period must be at least 12 months.
- History of or current clinical fibromyalgia or Juvenile Idiopathic Arthritis (JIA).
- Positive diagnosis of SLE.
- Patients with Type 1 or Type 2 Diabetes Mellitus.
- Patients with psoriasis.
- Patients with skin condition(s) or visible abnormalities at or near potential sites of injection (right and left abdomen; right and left thigh) that could mask the assessment of safety.
- Acute illness including current or chronic infections requiring antibiotics, or symptoms of a resolving illness, within 2 weeks prior to study.
- Any investigational drug within 3 months prior to study.
- Patients may not be receiving systemic corticosteroid therapy with the exception of inhaled corticosteroids for the treatment of asthma.
- Any clinically relevant abnormality as assessed by the Investigator, on screening history, physical exam, clinical laboratory, chest X-ray, or ECG, other than values consistent with rheumatoid arthritis, with the exception that liver function tests (ALP, ALT, AST) may be up to 1.5 times (X) the upper limit of normal (ULN).
- Positive serological test for HCV, HBsAg, HBcAg, HIV.
- QuantiFERON-positive patients may be enrolled with documented evidence that they have completed a prescribed course of antituberculous therapy.
- History of cardiovascular disease with New York Heart Association (NYHA) functional class II or greater; or history of stroke, or uncontrolled hypertension.
- History of lymphoproliferative disease, or organ allograft.
- Pregnancy or lactation, or WOCBP not currently using contraceptives or male partners of WOCBP not currently using contraceptives.
- History of cancer (except for in situ cancer, or limited stage cancer of the cervix, head and neck (squamous cell), thyroid, or skin (non-melanomatous) curatively treated with no sign of disease for > 5 years).
- Any physical or psychological condition that might prevent complete participation in the study, in the view of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ORTD-1-Low Dose
5.6 mg/0.45 mL of active study drug
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Once weekly, single subcutaneous injection of ORTD-1 at a volume of 0.45 mL.
Six weekly treatments; 28-day follow-up period.
Other Names:
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PLACEBO_COMPARATOR: Vehicle Control -Low Dose
Vehicle (Identical formulation without the active DP)
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Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL.
Six weekly treatments; 28-day follow-up period.
Other Names:
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EXPERIMENTAL: ORTD 1-High Dose
22.5 mg/1.8 mL of active study drug
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Two subcutaneous injections of ORTD-1 at two injection sites once weekly; 0.90 mL of ORTD-1 per each subcutaneous injection.
Six weekly treatments; 28-day follow-up period.
Other Names:
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PLACEBO_COMPARATOR: Vehicle Control -High Dose
Vehicle (Identical formulation without the active DP)
|
Two subcutaneous injections of vehicle at two injection sites once weekly; 0.90 mL of vehicle per each subcutaneous injection.
Six weekly treatments; 28-day follow-up period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events
Time Frame: 10 weeks
|
Safety will be assessed throughout the duration of the study (weeks 1 through 10) by monitoring of adverse events.
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10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity by measurement of anti-drug antibodies
Time Frame: Weeks 1, 3, 5, and 10
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Immunogenicity is the measurement of anti-drug (ORTD-1) antibodies (ADA) in serum.
ADA samples will be analyzed from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).
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Weeks 1, 3, 5, and 10
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Serum concentration of ORTD-1 from baseline
Time Frame: 10 weeks
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Serum concentration will be measured from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).
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10 weeks
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Cmax of ORTD-1
Time Frame: Week 1 through week 6
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Cmax (maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.
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Week 1 through week 6
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Tmax of ORTD-1
Time Frame: Week 1 through week 6
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Tmax (time of maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.
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Week 1 through week 6
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in disease activity
Time Frame: Weeks 1, 3, 5, and 10
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Disease activity score with C-reactive protein (DAS28-CRP) and ESR (Erythrocyte sedimentation rate) will be evaluated from the change in baseline (Visit 1) to Visit 9 (last patient visit).
28 joints are evaluated in the DAS28-CRP (Proximal interphalangeal, metacarpophalangeal, wrists, elbows, shoulders, knees) for swelling and tenderness.
The overall calculated value for DAS28-CRP uses the number of swollen and tender joints, the value recorded from the patient's CRP, and the Global Health patient assessment (0-100 mm; where 0 is very good and 100 is very bad health condition).
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Weeks 1, 3, 5, and 10
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Stohl, M.D., Ph.D., Keck School of Medicine of USC Division of Rheumatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 22, 2021
Primary Completion (ACTUAL)
October 12, 2021
Study Completion (ACTUAL)
October 12, 2021
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (ACTUAL)
February 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTD1-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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