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Rheumatoid ArthritisPhase 2NCT04057118

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.

A Phase 2 study testing SKI-O-703 in people with Rheumatoid Arthritis, run by Oscotec Inc. at 40 sites in 5 countries.

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 study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. 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?
SKI-O-703
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
40 sitesin 5 countries
Study dates
20 Mar 2019to 13 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must provide written, signed, informed consent.
  • Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism classification, for at least 6 months prior to first administration of study drug.
  • Patients must have active RA at screening and baseline (Day 1 of the study).
  • Patients who have active disease despite csDMARD (conventional synthetic disease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1 of the study.
  • Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumor necrosis factor alpha) biological agent(s) for the treatment of RA and meet the washout period prior to Day 1 of the study.

Who cannot join

  • Patients receiving oral agents, except for medications listed in inclusion criteria for the treatment of RA.
  • Patients who have previously received any other or biological agent for the treatment of RA, other than anti-TNF⍺ inhibitor(s).
  • Patients who have a current or past history of hepatitis B virus (HBV) infection; positive test for hepatitis C virus (HCV) antibody; positive test for human immunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acute infection requiring oral antibiotics within 2 weeks, or parenteral injection of antibiotics within 4 weeks prior to first administration of the study drug; other serious infection within 6 months prior to first administration of study drug; recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to first administration of the study drug; past or current granulomatous infections or other severe or chronic infection; positive test for tuberculosis (TB) or other evidence of TB.
  • Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
  • Patients with any other inflammatory or rheumatic diseases that could impact the evaluation of the effect of the study drug.
  • Patients with a history of malignancy within 5 years prior to first administration of the study drug, except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
Show all 9Show fewer
  • New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease or heart attack within 6 months prior to first administration of the study drug.
  • Female patients who are currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of the study drug.
  • Other protocol-defined inclusion/exclusion criteria could apply.

Trial locations and contacts

40 sites in 5 countries.

40 sites in 5 countries

United States12 sites

  • Oscotec Investigational Site (Site 3110)

    Beverly Hills, California, 90211

  • Oscotec Investigational Site (3106)

    Carrollton, Texas, 75010

  • Oscotec Investigational Site (Site 3107)

    Duncansville, Pennsylvania, 16635

  • Oscotec Investigational Site (Site 3111)

    Houston, Texas, 77034

  • Oscotec Investigational Site (Site 3108)

    Lexington, Kentucky, 40504

  • Oscotec Investigational Site (Site 3109)

    Mesquite, Texas, 75150

  • Oscotec Investigational (Site 3104)

    Miami Lakes, Florida, 33014

  • Oscotec Investigational Site (Site 3102)

    Oklahoma City, Oklahoma, 73103

  • Oscotec Investigational Site (Site 3103)

    San Antonio, Texas, 78229

  • Oscotec Investigational Site (Site 3112)

    Tampa, Florida, 33614

  • Oscotec Investigational Site (Site 3101)

    Tomball, Texas, 77375

  • Oscotec Investigational Site (Site 3105)

    Upland, California, 91786

Other trials in United States

Ukraine10 sites

  • Oscotec Investigational Site (Site 2510)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Oscotec Investigational Site (Site 2508)

    Kharkiv, 61058

  • Oscotec Investigational Site (Site 2501)

    Kyiv, 01023

  • Oscotec Investigational Site (Site 2503)

    Kyiv, 04050

  • Oscotec Investigational Site (Site 2502)

    Kyiv, 4107

  • Oscotec Investigational Site (Site 2507)

    Poltava, 36024

  • Oscotec Investigational Site (Site 2505)

    Ternopil, Ternopil Oblast, 46002

  • Oscotec Investigational Site (Site 2506)

    Vinnytsia, Vinnytsia Oblast, 21018

  • Oscotec Investigational Site (Site 2504)

    Vinnytsia, Vinnytsia Oblast, 21029

  • Oscotec Investigational Site (Site 2509)

    Vinnytsia, 21009

Other trials in Ukraine

Poland8 sites

  • Oscotec Investigational Site (Site 2201)

    Bialystok, Podlaskie Voivodeship, 15-879

  • Oscotec Investigational Site (Site 2204)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Oscotec Investigational Site (Site 2207)

    Lublin, Lublin Voivodeship, 20-582

  • Oscotec Investigational Site (Site 2206)

    Nadarzyn, 05-830

  • Oscotec Investigational Site (Site 2209)

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Oscotec Investigational Site (Site 2203)

    Poznan, Greater Poland Voivodeship, 61-397

  • Oscotec Investigational Site (Site 2202)

    Warsaw, Masovian Voivodeship, 01-518

  • Oscotec Investigational Site (Site 2208)

    Wroclaw, Lower Silesian Voivodeship, 53-224

Other trials in Poland

Russia8 sites

  • Oscotec Investigational Site (Site 2307)

    Kemerovo, 650066

  • Oscotec Investigational Site (Site 2304)

    Moscow, 119049

  • Oscotec Investigational Site (Site 2305)

    Moscow, 129110

  • Oscotec Investigational Site (Site 2308)

    Novosibirsk, 630099

  • Oscotec Investigational Site (Site 2306)

    Ryazan, 390026

  • Oscotec Investigational Site (Site 2302)

    Saint Petersburg, 194291

  • Oscotec Investigational Site (Site 2303)

    Saint Petersburg, 196084

  • Oscotec Investigational Site (Site 2301)

    Tomsk, 634050

Other trials in Russia

Czechia2 sites

  • Oscotec Investigational Site (Site 2101)

    Ostrava, 702 00

  • Oscotec Investigational Site (Site 2102)

    Zlín, 760 01

Other trials in Czechia

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies

This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.

Being tested
SKI-O-703, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • SKI-O-703Drug

    Oral administration, twice per day

  • PlaceboDrug

    Oral administration, twice per day

Study groups in NCT04057118
Study groupRoleWhat they receive
SKI-O-703 100 mgExperimentalNot described
Receives: Drug: SKI-O-703
SKI-O-703 200 mgExperimentalNot described
Receives: Drug: SKI-O-703
SKI-O-703 400 mgExperimentalNot described
Receives: Drug: SKI-O-703
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in Disease Activity Score

    Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein).

    Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(hsCRP+1)*1.10+1.15.

    High DAS28-hsCRP value indicates more severe disease activity, by value of >5.1 indicating relatively high disease activity, whereas value of <3.2 indicating achieved lower disease activity (no theoretical full range available).

    Measured: Baseline and Week 12

Secondary outcomes (6)

  1. • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score

    ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

    Measured: Baseline and Weeks 2, 4 8 and 12

  2. • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score

    ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

    Measured: Baseline and Weeks 2, 4 8 and 12

  3. • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score

    ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

    Measured: Baseline and Weeks 2, 4 8 and 12

  4. Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Change from baseline measured by disability index

    The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.

    Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability.

    A decrease in HAQ-DI score indicated an improvement in the participant's condition.

    Measured: Baseline and Weeks 2, 4 8 and 12

  5. Adverse Events (AEs)

    Measured: Up to Week 16

  6. Serious Adverse Events (SAEs)

    Measured: Up to Week 16

Timeline

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

  1. First posted15 Aug 2019
  2. Study start20 Mar 2019
  3. Primary completion13 Oct 2020
  4. Study completion13 Oct 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057118
Sponsor's protocol ID
OSCO-P2201
Status last verified
Apr 2024
First submitted
13 Aug 2019
Last updated
31 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKI-O-703 in people with Rheumatoid Arthritis, run by Oscotec Inc. at 40 sites in 5 countries.

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 5 inclusion and 9 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Ukraine, Poland, Russia, Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Disease Activity Score (time frame: Baseline and Week 12). 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 NCT04057118.

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 31 Jul 2024.

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