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

NCT04057118 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OSCO-P2201
• Study Type: interventional
• Target: 163
• Locations: 5 countries
• Sites: 40

Brief 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. 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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).

  Baseline and Week 12

Secondary Outcomes (6)

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

  Baseline and Weeks 2, 4 8 and 12

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

  Baseline and Weeks 2, 4 8 and 12

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

  Baseline and Weeks 2, 4 8 and 12

• Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

  Baseline and Weeks 2, 4 8 and 12

• Adverse Events (AEs)

  Up to Week 16

Study Arms (4)

SKI-O-703 100 mg

EXPERIMENTAL

Drug: SKI-O-703

SKI-O-703 200 mg

EXPERIMENTAL

Drug: SKI-O-703

SKI-O-703 400 mg

EXPERIMENTAL

Drug: SKI-O-703

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SKI-O-703 DRUG

Oral administration, twice per day

SKI-O-703 100 mg; SKI-O-703 200 mg; SKI-O-703 400 mg

Placebo DRUG

Oral administration, twice per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oscotec Inc.: lead

Study Sites (40)

Oscotec Investigational Site (Site 3110)

Beverly Hills, California, 90211, United States

Location

Oscotec Investigational Site (Site 3105)

Upland, California, 91786, United States

Location

Oscotec Investigational (Site 3104)

Miami Lakes, Florida, 33014, United States

Location

Oscotec Investigational Site (Site 3112)

Tampa, Florida, 33614, United States

Location

Oscotec Investigational Site (Site 3108)

Lexington, Kentucky, 40504, United States

Location

Oscotec Investigational Site (Site 3102)

Oklahoma City, Oklahoma, 73103, United States

Location

Oscotec Investigational Site (Site 3107)

Duncansville, Pennsylvania, 16635, United States

Location

Oscotec Investigational Site (3106)

Carrollton, Texas, 75010, United States

Location

Oscotec Investigational Site (Site 3111)

Houston, Texas, 77034, United States

Location

Oscotec Investigational Site (Site 3109)

Mesquite, Texas, 75150, United States

Location

Oscotec Investigational Site (Site 3103)

San Antonio, Texas, 78229, United States

Location

Oscotec Investigational Site (Site 3101)

Tomball, Texas, 77375, United States

Location

Oscotec Investigational Site (Site 2101)

Ostrava, 702 00, Czechia

Location

Oscotec Investigational Site (Site 2102)

Zlín, 760 01, Czechia

Location

Oscotec Investigational Site (Site 2203)

Poznan, Greater Poland Voivodeship, 61-397, Poland

Location

Oscotec Investigational Site (Site 2204)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Oscotec Investigational Site (Site 2208)

Wroclaw, Lower Silesian Voivodeship, 53-224, Poland

Location

Oscotec Investigational Site (Site 2207)

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Oscotec Investigational Site (Site 2202)

Warsaw, Masovian Voivodeship, 01-518, Poland

Location

Oscotec Investigational Site (Site 2201)

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Oscotec Investigational Site (Site 2206)

Nadarzyn, 05-830, Poland

Location

Oscotec Investigational Site (Site 2209)

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

Oscotec Investigational Site (Site 2307)

Kemerovo, 650066, Russia

Location

Oscotec Investigational Site (Site 2304)

Moscow, 119049, Russia

Location

Oscotec Investigational Site (Site 2305)

Moscow, 129110, Russia

Location

Oscotec Investigational Site (Site 2308)

Novosibirsk, 630099, Russia

Location

Oscotec Investigational Site (Site 2306)

Ryazan, 390026, Russia

Location

Oscotec Investigational Site (Site 2302)

Saint Petersburg, 194291, Russia

Location

Oscotec Investigational Site (Site 2303)

Saint Petersburg, 196084, Russia

Location

Oscotec Investigational Site (Site 2301)

Tomsk, 634050, Russia

Location

Oscotec Investigational Site (Site 2510)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Oscotec Investigational Site (Site 2505)

Ternopil, Ternopil Oblast, 46002, Ukraine

Location

Oscotec Investigational Site (Site 2506)

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

Oscotec Investigational Site (Site 2504)

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

Oscotec Investigational Site (Site 2508)

Kharkiv, 61058, Ukraine

Location

Oscotec Investigational Site (Site 2501)

Kyiv, 01023, Ukraine

Location

Oscotec Investigational Site (Site 2503)

Kyiv, 04050, Ukraine

Location

Oscotec Investigational Site (Site 2502)

Kyiv, 4107, Ukraine

Location

Oscotec Investigational Site (Site 2507)

Poltava, 36024, Ukraine

Location

Oscotec Investigational Site (Site 2509)

Vinnytsia, 21009, Ukraine

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

cevidoplenib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sungsil Lee/Team Leader of Clinical Development
• Organization: Oscotec Inc.

sslee@oscotec.com

+82316287624

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: March 20, 2019
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (8); RU (8); UA (10); US (12); CZ (2)