Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    Oryn Therapeutics

Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286789
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Oryn Therapeutics, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Low dose ORTD-1 Drug: Low dose vehicle control Drug: High dose ORTD-1 Drug: High dose vehicle control Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 22, 2021
Actual Primary Completion Date : October 12, 2021
Actual Study Completion Date : October 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ORTD-1-Low Dose
5.6 mg/0.45 mL of active study drug
Drug: Low dose ORTD-1
Once weekly, single subcutaneous injection of ORTD-1 at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
Other Name: ORTD-1

Placebo Comparator: Vehicle Control -Low Dose
Vehicle (Identical formulation without the active DP)
Drug: Low dose vehicle control
Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
Other Name: Placebo

Experimental: ORTD 1-High Dose
22.5 mg/1.8 mL of active study drug
Drug: High dose ORTD-1
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 Name: ORTD-1

Placebo Comparator: Vehicle Control -High Dose
Vehicle (Identical formulation without the active DP)
Drug: High dose vehicle control
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 Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Immunogenicity by measurement of anti-drug antibodies [ Time Frame: Weeks 1, 3, 5, and 10 ]
    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).

  2. Serum concentration of ORTD-1 from baseline [ Time Frame: 10 weeks ]
    Serum concentration will be measured from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).

  3. Cmax of ORTD-1 [ Time Frame: Week 1 through week 6 ]
    Cmax (maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.

  4. Tmax of ORTD-1 [ Time Frame: Week 1 through week 6 ]
    Tmax (time of maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.


Other Outcome Measures:
  1. Change from baseline in disease activity [ Time Frame: Weeks 1, 3, 5, and 10 ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04286789


Locations
Layout table for location information
United States, California
Keck School of Medicine of USC Division of Rheumatology
Los Angeles, California, United States, 90033
Orange County Research Center
Tustin, California, United States, 92780
United States, Florida
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
Sponsors and Collaborators
Oryn Therapeutics, LLC
Investigators
Layout table for investigator information
Principal Investigator: William Stohl, M.D., Ph.D. Keck School of Medicine of USC Division of Rheumatology
Layout table for additonal information
Responsible Party: Oryn Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04286789    
Other Study ID Numbers: ORTD1-002
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases