Rheumatoid ArthritisPhase 2NCT04049448
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing ABX464 in people with Rheumatoid Arthritis, run by Abivax S.A. at 14 sites in 4 countries.
Trial summary
A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ABX464
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 25 Oct 2019to 23 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period;
- Criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment:
- Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα.
Who cannot join
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Poland6 sites
ClinicMed Daniluk, Nowak Sp. J.
Bialystok
Pratia MCM
Krakow
Zespół Poradni Specjalistycznych REUMED
Lublin
NZOZ Lecznica MAK-MED S.C.
Nadarzyn
Medyczne Centrum Hetmańska
Poznan
National Institute of Geriatrics
Warsaw
France3 sites
CHU de Brest - Hôpital Cavale Blanche
Brest
CHU DE MONTPELLIER - Hôpital Lapeyronie
Montpellier
CHR d'Orléans
Orléans
Hungary3 sites
Complex Medical Centre - Déli Klinika
Budapest
CRU Hungary Ltd.
Miskolc
CMed Rehabilitációs és Diagnosztikai Központ
Székesfehérvár
About this study
Official title: A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis
A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.
Read the detailed description
This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.
All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).
The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.
Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).
- Conditions
- Rheumatoid Arthritis
- Being tested
- ABX464
- Keywords
- moderate to severe Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).
| Study group | Role | What they receive |
|---|---|---|
| ABX464 50 mg | Experimental | All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks) Receives: Drug: ABX464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
Incidence of adverse events emerging during the treatment
Measured: through study completion (average of 104 weeks)
Secondary outcomes (8)
Proportion of patients achieving Low Disease Activity (LDA)
Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2
Measured: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
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
Measured: Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission
The SDAI remission is considered achieved if the SDAI score ≤ 3.3
Measured: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving Clinical Disease Activity (CDAI) remission
The CDAI remission is considered achieved if the CDAI score ≤ 2.8
Measured: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving ACR20/50/70 response
The categorical American College of Rheumatology 20% or 50% or 70% (ACR20/50/70) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% or 50% or 70% improvement in the ACR response.
Measured: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response
Proportion 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
Measured: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Time to onset of the Low Disease Activity (LDA) remission
time when DAS28-ESR <=3.2
Measured: up to 104 weeks
Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
The ACR/EULAR 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.
Time to onset will be when this criteria will be ≤ 1
Measured: up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start25 Oct 2019
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, follow-up study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Desroys du Roure, PharmD, Study chair, Abivax S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049448
- Sponsor's protocol ID
- ABX464-302
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2019
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04049448
- Acronym / sponsor ID
- ABX464-302
- Conditions
- Rheumatoid Arthritis
- Keywords
- moderate to severe Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.
Detailed description
This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.
All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).
The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.
Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, follow-up study
| Arm | Type | Receives |
|---|---|---|
| ABX464 50 mg | Experimental | Drug: ABX464All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks) |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period;
- Criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment:
- Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα.
Key exclusion criteria (1 listed)
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX464All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks). | Drug | ABX464 50 mg |
Primary outcome
Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
Time frame: through study completion (average of 104 weeks)
Incidence of adverse events emerging during the treatment
8 secondary outcomes
Proportion of patients achieving Low Disease Activity (LDA)
Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
Time frame: Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission
Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving Clinical Disease Activity (CDAI) remission
Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving ACR20/50/70 response
Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response
Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Time to onset of the Low Disease Activity (LDA) remission
Time frame: up to 104 weeks
Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
Time frame: up to 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Desroys du Roure, PharmD study chair
Abivax S.A.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX464 in people with Rheumatoid Arthritis, run by Abivax S.A. at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland, France, Hungary, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity (time frame: through study completion (average of 104 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.