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Rheumatoid ArthritisPhase 1NCT04286789

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

A Phase 1 study testing Low dose ORTD-1 and High dose ORTD-1 in people with Rheumatoid Arthritis, run by Oryn Therapeutics, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Low dose ORTD-1 and High dose ORTD-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
3 sitesUnited States
Study dates
22 Mar 2021to 12 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Keck School of Medicine of USC Division of Rheumatology

    Los Angeles, California, 90033

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

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

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.

Being tested
Low dose ORTD-1, Low dose vehicle control, High dose ORTD-1, High dose vehicle control
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose ORTD-1Drug

    Also called 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.

  • Low dose vehicle controlDrug

    Also called Placebo

    Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.

  • High dose ORTD-1Drug

    Also called 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.

  • High dose vehicle controlDrug

    Also called Placebo

    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.

Study groups in NCT04286789
Study groupRoleWhat they receive
ORTD-1-Low DoseExperimental5.6 mg/0.45 mL of active study drug
Receives: Drug: Low dose ORTD-1
Vehicle Control -Low DosePlacebo comparatorVehicle (Identical formulation without the active DP)
Receives: Drug: Low dose vehicle control
ORTD 1-High DoseExperimental22.5 mg/1.8 mL of active study drug
Receives: Drug: High dose ORTD-1
Vehicle Control -High DosePlacebo comparatorVehicle (Identical formulation without the active DP)
Receives: Drug: High dose vehicle control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events

    Safety will be assessed throughout the duration of the study (weeks 1 through 10) by monitoring of adverse events.

    Measured: 10 weeks

Secondary outcomes (4)

  1. Immunogenicity by measurement of anti-drug antibodies

    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).

    Measured: Weeks 1, 3, 5, and 10

  2. Serum concentration of ORTD-1 from baseline

    Serum concentration will be measured from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).

    Measured: 10 weeks

  3. Cmax of ORTD-1

    Cmax (maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.

    Measured: Week 1 through week 6

  4. Tmax of ORTD-1

    Tmax (time of maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.

    Measured: Week 1 through week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start22 Mar 2021
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04286789
Sponsor's protocol ID
ORTD1-002
Status last verified
Oct 2021
First submitted
25 Feb 2020
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose ORTD-1 and High dose ORTD-1 in people with Rheumatoid Arthritis, run by Oryn Therapeutics, LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04286789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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