A Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celltrion Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

17 Dec 2024 → 13 Apr 2026

Decision date (initial)

2024-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Celltrion, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

• To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12.

Secondary objectives 2

1. To evaluate the additional efficacy of CT-P13 SC over Placebo up to Week 12
2. To evaluate additional efficacy, pharmacokinetics (PK), and overall safety including immunogenicity of CT-P13 SC up to Week 52

Conditions and MedDRA coding

Rheumatoid arthritis

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient who is male or female aged 18 to 75 years old (both inclusive).
2. Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA. Note. Medical records or sufficient documentation supporting RA diagnosis based on the 2010 ACR/EULAR classification criteria must be available in the source documents.
3. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening.
4. Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1).
5. Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results: a. Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (SI [International System of Units] units: 0.84mL/s) b. Serum alanine aminotransferase (ALT) <2.5 × ULN c. Serum aspartate aminotransferase (AST) <2.5 × ULN d. Serum total bilirubin <2 × ULN
6. Patient who has the following hematology laboratory test results at Screening: a. Hemoglobin ≥8.5 g/dL (SI units: ≥85 g/L or 5.28 mmol/L) b. White blood cell count ≥3.5 × 10^3 cells/µL (SI units: ≥3.5 × 10^9 cells/L) c. Neutrophil count ≥1.5 × 10^3 cells/µL (SI units: ≥1.5 × 10^9 cells/L) d. Platelet count ≥100 × 10^3 cells/µL (SI units: ≥100 × 10^9 cells/L)

Exclusion criteria 3

1. Patient who has previously received investigational or licensed product; biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose.
2. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
3. Patient who has received or has plan to receive any of following prohibited medications or treatments: a. Intra-articular corticosteroids within 4 weeks prior to the first administration of the study drug (Day 1). b. Disease-modifying antirheumatic drugs (DMARDs), other than MTX, including hydroxychloroquine, chloroquine, or sulfasalazine, within 4 weeks prior to the first administration of the study drug (Day 1). c. Alkylating agents within 12 months prior to the first administration of the study drug (Day 1) d. Live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 1), or any planned live or live-attenuated vaccination during the study period e. Any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the first administration of the study drug (Day 1) or planned within 12 weeks after the first administration of the study drug (Day 1) f. Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celltrion Inc.

Sponsor organisation

Celltrion Inc.

Address

23 Academy-Ro, Yeonsu-Gu Yeonsu-Gu

City

Incheon

Postcode

22014

Country

Korea, Republic of

Scientific contact point

Organisation

Celltrion Inc.

Contact name

Clinical Planning

Public contact point

Organisation

Celltrion Inc.

Contact name

Clinical Operation

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications