Trial Outcomes & Findings for Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis (NCT NCT03813199)

NCT ID: NCT03813199

Last Updated: 2023-02-15

Results Overview

TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: through study completion, an average of 15 weeks
• Results posted on: 2023-02-15

Participant Flow

Participant milestones

Measure	ABX464 50mg + Methotrexate Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Study STARTED	21	19	20
Overall Study COMPLETED	18	6	19
Overall Study NOT COMPLETED	3	13	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Total n=60 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 11.4 • n=21 Participants	54.4 years STANDARD_DEVIATION 10.6 • n=19 Participants	58.6 years STANDARD_DEVIATION 11.0 • n=20 Participants	57.0 years STANDARD_DEVIATION 11.0 • n=60 Participants
Sex: Female, Male Female	15 Participants n=21 Participants	11 Participants n=19 Participants	11 Participants n=20 Participants	37 Participants n=60 Participants
Sex: Female, Male Male	6 Participants n=21 Participants	8 Participants n=19 Participants	9 Participants n=20 Participants	23 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: through study completion, an average of 15 weeks

TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo	18 Participants	18 Participants	14 Participants

SECONDARY outcome

Timeframe: at Week 12

Population: Intent to treat population

The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving ACR20 Response	9 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population

Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving ACR20/50/70 Response ACR20 response	9 Participants	3 Participants	4 Participants
Number of Patients Achieving ACR20/50/70 Response ACR50 response	5 Participants	2 Participants	1 Participants
Number of Patients Achieving ACR20/50/70 Response ACR70 response	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat

Change from baseline in C-reactive protein (CRP) at Week 12

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in C-reactive Protein (CRP)	-4.31 mg/L Standard Deviation 28.83	0.62 mg/L Standard Deviation 4.89	-0.65 mg/L Standard Deviation 18.74

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving DAS28-CRP Response	14 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).

DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]	-1.41 score on a scale Standard Deviation 1.45	-0.72 score on a scale Standard Deviation 1.13	-0.60 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	-2.6 mm/h Standard Deviation 19.3	-0.3 mm/h Standard Deviation 6.8	-2.7 mm/h Standard Deviation 16.6

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR < 2.6

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to Treat

The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).

DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

change from baseline at weeks 12: the bigger negative score shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)	-1.43 mm/h Standard Deviation 1.39	-0.74 mm/h Standard Deviation 1.11	-0.59 mm/h Standard Deviation 1.00

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).

SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score >11 to 26 included. A high activity is defined by a SDAI score >26. Change from Baseline: the higher negative number shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Simplified Disease Activity Index Score (SDAI)	-20.21 score on a scale Standard Deviation 33.27	-9.37 score on a scale Standard Deviation 14.44	-7.58 score on a scale Standard Deviation 22.69

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).

CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score >10 to 22 included. A high activity is defined by a CDAI score >22. Change from Baseline: the higher negative number shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Clinical Disease Activity Index Score (CDAI)	-15.89 score on a scale Standard Deviation 13.29	-9.99 score on a scale Standard Deviation 15.85	-6.93 score on a scale Standard Deviation 10.13

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving Low Disease Activity (LDA)	4 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving Clinical Disease Activity (CDAI) Remission	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population

The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: intent to treat

Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Tender/Painful Joint Count (TJC28)	-6.8 joints Standard Deviation 6.4	-4.1 joints Standard Deviation 6.6	-2.9 joints Standard Deviation 3.8

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to treat

Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Swollen Joint Count (SJC)	-4.4 joints Standard Deviation 4.2	-3.2 joints Standard Deviation 5.3	-2.1 joints Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to Treat

Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Pain Visual Analog Scale	-2.63 units on a scale Standard Deviation 2.43	-0.89 units on a scale Standard Deviation 1.97	-0.78 units on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to Treat

Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Patient Global Assessment of Disease (PtGA)	-1.44 units on a scale Standard Deviation 1.92	-0.89 units on a scale Standard Deviation 1.93	-0.36 units on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to treat

Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Investigator Global Assessment of Disease (PrGA)	-3.26 units on a scale Standard Deviation 2.7	-1.89 units on a scale Standard Deviation 2.95	-1.63 units on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent to Treat

Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.

The 8 scores of the 8 sections are summed and divided by the number of section answered.

This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment

Outcome measures

Measure	ABX464 50mg + Methotrexate n=21 Participants Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 Participants Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 Participants Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	-0.4345 units on a scale Standard Deviation 0.6182	-0.1053 units on a scale Standard Deviation 0.3443	-0.1813 units on a scale Standard Deviation 0.4824

Adverse Events

ABX464 50mg + Methotrexate

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

ABX464 100mg + Methotrexate

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo + Methotrexate

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABX464 50mg + Methotrexate n=21 participants at risk Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 participants at risk Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 participants at risk Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Cardiac disorders Atrial fibrillation	0.00% 0/21 • 15 weeks	5.3% 1/19 • Number of events 1 • 15 weeks	0.00% 0/20 • 15 weeks
Infections and infestations Covid-19	0.00% 0/21 • 15 weeks	0.00% 0/19 • 15 weeks	5.0% 1/20 • Number of events 1 • 15 weeks

Other adverse events

Measure	ABX464 50mg + Methotrexate n=21 participants at risk Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	ABX464 100mg + Methotrexate n=19 participants at risk Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Placebo + Methotrexate n=20 participants at risk Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Nervous system disorders Headache	38.1% 8/21 • Number of events 19 • 15 weeks	52.6% 10/19 • Number of events 16 • 15 weeks	20.0% 4/20 • Number of events 6 • 15 weeks
Gastrointestinal disorders nausea	14.3% 3/21 • Number of events 4 • 15 weeks	47.4% 9/19 • Number of events 12 • 15 weeks	0.00% 0/20 • 15 weeks
Gastrointestinal disorders Diarrhoea	19.0% 4/21 • Number of events 7 • 15 weeks	36.8% 7/19 • Number of events 11 • 15 weeks	5.0% 1/20 • Number of events 1 • 15 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21 • 15 weeks	10.5% 2/19 • Number of events 3 • 15 weeks	5.0% 1/20 • Number of events 1 • 15 weeks
Gastrointestinal disorders Abdominal pain upper	23.8% 5/21 • Number of events 6 • 15 weeks	21.1% 4/19 • Number of events 10 • 15 weeks	5.0% 1/20 • Number of events 1 • 15 weeks
Gastrointestinal disorders abdominal pain	9.5% 2/21 • Number of events 3 • 15 weeks	5.3% 1/19 • Number of events 1 • 15 weeks	0.00% 0/20 • 15 weeks
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Number of events 1 • 15 weeks	15.8% 3/19 • Number of events 3 • 15 weeks	0.00% 0/20 • 15 weeks
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	9.5% 2/21 • Number of events 2 • 15 weeks	5.3% 1/19 • Number of events 1 • 15 weeks	5.0% 1/20 • Number of events 1 • 15 weeks
Gastrointestinal disorders Vomiting	9.5% 2/21 • Number of events 2 • 15 weeks	15.8% 3/19 • Number of events 4 • 15 weeks	0.00% 0/20 • 15 weeks
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Number of events 2 • 15 weeks	5.3% 1/19 • Number of events 1 • 15 weeks	0.00% 0/20 • 15 weeks

Additional Information

Vice President Clinical Operations

Abivax

Phone: 01 53 83 08 41

Email: paul.gineste@abivax.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place