A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Burfiralimab (hzVSF-v13) added to disease-modifying antirheumatic drugs in patient with moderate to severe Rheumatoid Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immunemed Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

completed 11 Jun 2024

Decision date (initial)

2024-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of low (200 mg) and high (600 mg) doses of burfiralimab compared to placebo on disease activity in participants with moderate to severe RA who have had an inadequate response to at least 2 DMARD therapies

Secondary objectives 1

1. To evaluate the efficacy of burfiralimab compared to placebo on other measures of disease activity

Conditions and MedDRA coding

rheumatoid arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Participant has provided written informed consent for the study.
2. Participant is of either sex, aged ≥18 years to ≤80 years.
3. Participant has a diagnosis of adult-onset RA for at least 3 months prior to Screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
4. Participant has moderate to severe RA at Screening and Baseline, defined by the presence of the following symptoms:  ≥2 swollen joints based on 66 joint count,  ≥6 tender joints based on 68 joint count.
5. Participant has had a continued disease activity despite at least 3 months of adequate therapy or discontinued for an AE or intolerance as stated in the participant chart.
6. Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs.
7. Participant has taken an antirheumatic medication for a minimum of 3 months prior to Screening at a stable dose for at least 1 month.
8. Participant is positive for anti-citrullinated protein antibodies (ACPA).
9. Participant has a C-reactive protein (CRP) > upper limit normal (ULN) (5.0 g/L).
10. Participant has a negative tuberculosis test at Screening, defined as either negative QuantiFERON® test or purified protein derivative <5 mm of induration at 48 to 72 hours after the test was placed.
11. Participant is not pregnant and not lactating.
12. If of childbearing potential, participant is practicing 1 of the following highly effective methods of birth control while on study and for 120 days after the last dose of the IP
13. If participant is sexually active and has a partner who may become pregnant (i.e., neither surgically sterile nor postmenopausal), agrees to use adequate contraception (e.g., sterilization, birth control pills, Depo Provera injections, or contraceptive implants) while on study and for 120 days after the last dose of the IP.
14. Participant agrees to refrain from donating sperm during study and for 120 days following the last treatment with the IP.
15. Participant is able to understand all study information provided and is willing to return to the study facility for all visits, including follow-up evaluations.

Exclusion criteria 10

1. Participant has known allergy or significant adverse reaction to the IP or related compounds.
2. Participant has Class IV RA according to ACR revised response criteria.
3. Participant has 1 or more significant concurrent medical conditions per investigator judgment
4. Participant has known history of prosthetic or native joint infection or human immunodeficiency virus or neurologic symptoms suggestive of central nervous system demyelinating disease.
5. Participant has a chronic inflammatory disease or connective tissue disease other than RA, including but not limited to; systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non radiographic axial spondylarthritis, reactive arthritis, gout, scleroderma, polymyositis, dermatomyositis and/or active fibromyalgia and/or multiple sclerosis.
6. Participant has reported any of the below criteria or has any other significant laboratory abnormality at Screening, which, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this study or interfere with the interpretation of the study results
7. Participant is pregnant or breast feeding or planning to become pregnant while enrolled in the study and for 120 days after the last dose of the IP.
8. Participant has received any IP or was treated with an investigational device within 30 days before enrollment in this study.
9. Participant has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
10. Participant has any disorder that might interfere with the conduct of the study in the opinion of the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving clinical response according to the American College of Rheumatology (ACR) 20 criteria at Week 12

Secondary endpoints 7

1. Clinical response at Week 12, assessed as the percentage of participants achieving low disease activity (LDA) as measured by: o ACR50 (70) = 50% (70%) improvement in the ACR core set values o Disease Activity Score 28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) <3.2 o Clinical Disease Activity Index (CDAI) ≤10
2. Clinical response at Week 12, assessed as the percentage of participants attaining remission as measured by: o DAS28-CRP ≤2.6 o CDAI ≤2.8
3. Clinical response at Week 12, assessed as (mean) change from Baseline in: o DAS28-CRP o CDAI
4. Clinical response at Week 12, assessed as the (mean) hybrid ACR score
5. Improvement in physical function at Week 12, assessed as the percentage of participants with: o A ≥0.22 decrease in patient reported ACR Core Set Values in participant’s assessment of physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI) o A <0.5 in participant’s assessment of physical function using the HAQ DI
6. Pain relief at Week 12, assessed by the (mean) change from Baseline of the 11 point numeric scale (NRS 11)
7. Health-related quality of life at Week 12 as assessed by (mean) change from baseline of the EQ-5D-5L Health Questionnaire (EuroQoL)

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immunemed Inc.

Sponsor organisation

Immunemed Inc.

Address

Room2-2 Bldg 3 Biotown, 32 Soyanggang-Ro 32 Soyanggang-Ro

City

Chuncheon

Postcode

24232

Country

Korea, Republic of

Scientific contact point

Organisation

Immunemed Inc.

Contact name

Grace Hur

Public contact point

Organisation

Immunemed Inc.

Contact name

Grace Hur

Third parties 2

Locations

6 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Application history

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