Rheumatoid Arthritis (RA)Phase 2NCT06671054
A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis
A Phase 2 study testing AP1189, 40 mg, AP1189, 70 mg and AP1189, 100 mg in people with Rheumatoid Arthritis (RA), run by SynAct Pharma Aps at 11 sites in 5 countries.
Trial summary
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- AP1189, 40 mg, AP1189, 70 mg and AP1189, 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 1 Oct 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before undergoing any trial-specific procedure.
- Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.
- Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)
- Participants with at least 6/68 tender and 6/66 swollen joints at Screening Visit and Baseline.
- Participants with "high" disease activity as documented by a Disease Activity Score 28 (DAS28) (C-Reactive Protein - CRP) index score > 5.1 at screening, and Clinical disease activity index (CDAI) >22 at Screening Visit and Baseline.
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- Participants with serum high sensitive C-Reactive Protein (hsCRP) ≥3 mg/L at the time of screening.
- Participants positive for serum rheumatoid factor (RF), AND/OR anti-cyclic citrullinated peptide antibodies (anti-CCP). If seronegative RA, hsCRP ≥6 mg/L at the time of screening.
- Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.
- Females of childbearing potential must have a negative pregnancy test at screening and again at baseline.
- Sexually active female participants of childbearing potential and male participants are excluded if not practicing two different methods of birth control with their partner during the study and for 90 days after the last dose of study drug or who will not remain abstinent during the study and for 90 days after the last dose.
Who cannot join
- Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.
- Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.
- Current inflammatory joint disease other than RA.
- Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.
- Gastrointestinal diseases known to interfere with the absorption or excretion of medications.
- Severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
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- Malignancy active during the 12 months preceding the Screening Visit.
- Acute hepatitis, chronic hepatitis, or detection of any unexplained elevation of serum ALT or AST greater than 1.5-fold ULN, at least twice in the 6 months before the Screening Visit) or HIV infection.
- History of alcohol or drug abuse during the 12 months preceding the Screening Visit.
- Vaccination with live vaccines during the 6 weeks preceding the Screening Visit.
- Haemoglobin <9 g/dL or Haematocrit <30% at the Screening Visit
- White blood cell (WBC) count <3.0 x 109/L at the Screening Visit.
- Absolute neutrophil count <1.2 x 109/L at the Screening Visit.
- Platelet count <100 x 109/L at the Screening Visit.
- Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.
- Estimated creatinine clearance less than 45 mL/min/1.73 m2 (MDRD) at the Screening Visit.
- 12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.
- Positive QuantiFERON-in-Tube test (QFG-IT).
- Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.
- Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.
- Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.
- Use of other investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.
- Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
Poland4 sites, 4 recruiting
- Recruiting
M2Mmed
Chorzów, 41-500
Magdalena Włoch-Targońska, Dr., m.wloch-targonska@m2m-badania.pl
- Recruiting
Vita Longa Sp. z o. o.
Katowice, 41-500
Barbara Stasiuk, Dr., barbara.stasiuk@researchsolutions.pl
- Recruiting
Medyczne Centrum Hetmańska
Poznan, 60-218
Piotr Leszczyński, Dr., piotr.leszczynski@centrum-hetmanska.pl
- Recruiting
DC-MED Michal Kowalski S.K.
Swidnica, 58-100
Małgorzata Rajewska, Dr., k.hliwa@dc-med.pl
w.surowka@dc-med.pl
United States3 sites, 3 recruiting
- Recruiting
Nouvelle Clinical Research LLC
Cutler Bay, Florida, 33189
Rawan Jumean, MD, info@nouvelleclinicalresearch.com
- Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Alan Kiwitz, MD, altoonaresearch@gmail.com
(814) 693-0300
- Recruiting
Millennium Medical Research LLC
Miami, Florida, 33126
Ramon Morada, drmoreda@millenniummedresearch.com
Bulgaria2 sites, 2 recruiting
- Recruiting
Diagnostic Consultative Center Aleksandrovska
Sofia, 1431
Delina Ivanova, Dr., dr-delina@mail.bg
- Recruiting
Medical Center Tera Medico
Vratsa, 3000
Tanya Tsvetanova, Dr., t_cvetanova@abv.bg
Denmark1 site, 1 recruiting
- Recruiting
Sanos Clinic Herlev
Herlev, 2730
Mads Bakkegaard, MD, info@sanosclinic.com
Moldova1 site, 1 recruiting
- Recruiting
IMSP Spitalul Clinic Municipal "Sfanta Treime"
Chisinau, 2068
Svetlana Agachi, Ass. Prof., svetlana.agachi@usmf.md
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
Read the detailed description
The purpose of the trial is to evaluate the efficacy, safety and tolerability of 12 weeks daily treatment of oral AP1189 at the doses of 40, 70, or 100 mg in combination with oral MTX compared to oral MTX alone.
The aim is to have 240 participants randomized to one of the 4 treatment groups, in a 1:1:1:1 ratio and treated with both AP1189/Placebo and MTX.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- AP1189, 40 mg, AP1189, 70 mg, AP1189, 100 mg, AP1189 matching placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP1189, 40 mgDrug
AP1189 tablets for oral use
AP1189, 70 mgDrug
AP1189 tablets for oral use
AP1189, 100 mgDrug
AP1189 tablets for oral use
AP1189 matching placeboDrug
AP1189 tablets for oral use
| Study group | Role | What they receive |
|---|---|---|
| AP1189 40 mg | Experimental | 12 weeks daily treatment of oral AP1189 40 mg as add-on to Methotrexate (MTX) Receives: Drug: AP1189, 40 mg |
| AP1189 70 mg | Experimental | 12 weeks daily treatment of oral AP1189 70 mg as add-on to Methotrexate (MTX) Receives: Drug: AP1189, 70 mg |
| AP1189 100 mg | Experimental | 12 weeks daily treatment of oral AP1189 100 mg as add-on to Methotrexate (MTX) Receives: Drug: AP1189, 100 mg |
| Placebo | Experimental | 12 weeks daily treatment of oral AP1189 matching placebo as add-on to Methotrexate (MTX) Receives: Drug: AP1189 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP)
Absolute change from baseline in DAS28-CRP at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynAct Pharma Aps
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671054
- Sponsor's protocol ID
- SynAct-CS008
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.
- ClinicalTrials.gov ID
- NCT06671054
- Acronym / sponsor ID
- SynAct-CS008
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- SynAct Pharma ApsIndustry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Nov 2024 (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.
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
Detailed description
The purpose of the trial is to evaluate the efficacy, safety and tolerability of 12 weeks daily treatment of oral AP1189 at the doses of 40, 70, or 100 mg in combination with oral MTX compared to oral MTX alone.
The aim is to have 240 participants randomized to one of the 4 treatment groups, in a 1:1:1:1 ratio and treated with both AP1189/Placebo and MTX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AP1189 40 mg | Experimental | Drug: AP1189, 40 mg12 weeks daily treatment of oral AP1189 40 mg as add-on to Methotrexate (MTX) |
| AP1189 70 mg | Experimental | Drug: AP1189, 70 mg12 weeks daily treatment of oral AP1189 70 mg as add-on to Methotrexate (MTX) |
| AP1189 100 mg | Experimental | Drug: AP1189, 100 mg12 weeks daily treatment of oral AP1189 100 mg as add-on to Methotrexate (MTX) |
| Placebo | Experimental | Drug: AP1189 matching placebo12 weeks daily treatment of oral AP1189 matching placebo as add-on to Methotrexate (MTX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated informed consent obtained before undergoing any trial-specific procedure.
- Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.
- Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)
- Participants with at least 6/68 tender and 6/66 swollen joints at Screening Visit and Baseline.
Key exclusion criteria (23 listed)
- Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.
- Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.
- Current inflammatory joint disease other than RA.
- Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.
- Gastrointestinal diseases known to interfere with the absorption or excretion of medications.
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 |
|---|---|---|
| AP1189, 40 mgAP1189 tablets for oral use | Drug | AP1189 40 mg |
| AP1189, 70 mgAP1189 tablets for oral use | Drug | AP1189 70 mg |
| AP1189, 100 mgAP1189 tablets for oral use | Drug | AP1189 100 mg |
| AP1189 matching placeboAP1189 tablets for oral use | Drug | Placebo |
Primary outcome
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP)
Time frame: Week 12
Absolute change from baseline in DAS28-CRP at Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP1189, 40 mg, AP1189, 70 mg and AP1189, 100 mg in people with Rheumatoid Arthritis (RA), run by SynAct Pharma Aps at 11 sites in 5 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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, United States, Bulgaria, Denmark, Moldova. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Jonassen, MD (+45 4015 6669, tj@synactpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP) (time frame: Week 12). 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 6 Oct 2025.