A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mabxience Research S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

7 Apr 2025 → 23 Feb 2026

Decision date (initial)

2024-09-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

mAbxience Research SLU

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Therapy, Efficacy, Pharmacokinetic

To compare the efficacy of MB04 with European Union (EU)-sourced Enbrel® at Week 24 in terms of American College of Rheumatology 20% response criteria (ACR20) in patients with moderate to severe rheumatoid arthritis (RA) on methotrexate (MTX) therapy

Secondary objectives 4

1. To evaluate the efficacy of MB04 compared to EU-sourced Enbrel® using a time response model for ACR20 and other relevant efficacy endpoints, other than ACR20 at Week 24, in patients with moderate to severe RA despite MTX therapy. At Week 36, relevant efficacy endpoints will be assessed for effect maintenance evaluation.
2. To assess and compare the trough concentrations (Ctrough) of MB04 with EU-sourced Enbrel®.
3. To assess and compare safety, tolerability, and immunogenicity of MB04 and EU-sourced Enbrel®.
4. To assess and compare pharmacokinetics (Ctrough), safety, tolerability, and immunogenicity of MB04 after a single transition from EU-sourced Enbrel® to the biosimilar candidate.

Conditions and MedDRA coding

Rheumatoid Arthritis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult (male or female) between 18 to 75 years
2. Rheumatoid Arthritis (RA) diagnosis ≥6 months prior to randomization (time from diagnosis <15 years)
3. Moderately to severe RA despite appropriate MTX at baseline therapy
4. Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization
5. Stable dose of NSAID and /or other analgesics for at least 4 weeks prior to randomization, when used
6. Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used
7. Patients who are otherwise medically stable according to investigator's discretion
8. Agree to use highly effective contraceptive methods up to 6 months after last dose

Exclusion criteria 9

1. Previously treated with any biologic or targeted synthetic DMARD
2. Previously treated with any monoclonal antibody for other condition than RA
3. Hypersensitivity to any component of study drug and/or prefilled syringe components
4. Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA
5. Systemic manifestations of RA other that rheumatoid nodules or secondary Sjogren´s syndrome
6. Active infection or potentially relapsing infections that could have a severe outcome. Latent tuberculosis infection detected during screening should start an approved treatment regimen according to standard of care and rescreened
7. Solid or hematologic malignancy within the past 5 years
8. Pregnant and breastfeeding women
9. Any medical condition in the opinion of the investigator that would be a risk for safety, cooperation in the study or interferes with the interpretation of the study results

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ACR20 response rate at Week 24 (proportion of patients achieving ACR20 response at Week 24).

Secondary endpoints 8

1. ACR20 response rate at Weeks 4, 8, and 12 (for treatment onset evaluation) and Week 36 of dosing (for effect maintenance evaluation).
2. American College of Rheumatology 50% response criteria (ACR50) response rate at Weeks 4, 8, 12, 24, and 36 of dosing.
3. American College of Rheumatology 70% response criteria (ACR70) response rate at Weeks 4, 8, 12, 24, and 36 of dosing.
4. Changes over time in the disease activity score at 28 joints (DAS28) measured at Weeks 4, 8, 12, 24, and 36.
5. Numeric index of the ACR response (ACR-N) at Week 24.
6. Area under the curve (AUC) of the ACR-N from first administration up to Week 24.
7. AUC of the change in DAS28 from first administration up to Week 24.
8. Classification of European League Against Rheumatism (EULAR) response from first administration up to Week 24.

Investigational products

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

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mabxience Research S.L.

Sponsor organisation

Mabxience Research S.L.

Address

Calle De Manuel Pombo Angulo 28 Floor 3

City

Madrid

Postcode

28050

Country

Spain

Scientific contact point

Organisation

Mabxience Research S.L.

Contact name

Susana Millán

Public contact point

Organisation

Mabxience Research S.L.

Contact name

Susana Millán

Third parties 8

Locations

4 EU/EEA countries · 51 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 3 · Art. 38 CTR

Results and documents

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

Documents 20 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