Rheumatoid ArthritisPhase 2EXPANDNCT05516979
A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
A Phase 2 study testing 100 mg AP1189 in people with Rheumatoid Arthritis, run by SynAct Pharma Aps at 1 site in Moldova.
Trial summary
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 100 mg AP1189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteMoldova
- Study dates
- 26 Sep 2022to 20 Jul 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts).
- Candidate for MTX treatment
- Is about to begin treatment with MTX
- Must meet at least one of the following parameters at Screening:
- positive result for anti-CCP or RF
- Serum CRP ≥ 6 mg/L
- Highly active RA (CDAI > 22) at screening and baseline
- Negative QuantiFERON-in-Tube test (QFG-IT)
- Females of child-bearing potential must use of highly effective birth control method
Main Exclusion Criteria:
- Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
- Prior history of or current inflammatory joint disease other than RA
- Subjects with fibromyalgia
- Use of hydroxychloroquine within 4 weeks prior the Screening Visit
- Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
- Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- Have prior renal transplant, current renal dialysis, or severe renal insufficiency
- Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
- Neuropathies or other painful conditions that might interfere with pain evaluation
- Body weight of >150 kg
- HBsAg positive and/or Anti-HBc with sign of current infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).
- Conditions
- Rheumatoid Arthritis
- Being tested
- 100 mg AP1189, 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.
100 mg AP1189Drug
Also called AP1189 tablets for oral use
AP1189 tablets for oral use
PlaceboDrug
Matching placebo for oral use
| Study group | Role | What they receive |
|---|---|---|
| 100 mg AP1189 | Experimental | Treatment period of 12 weeks given as 1 tablet daily Receives: Drug: 100 mg AP1189 |
| Placebo | Placebo comparator | Treatment period of 12 weeks given as 1 tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reported AEs
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Measured: 12 weeks
Change in ACR20
The change in American College of Rheumatology 20% (ACR20) compared to baseline
Measured: 12 weeks
Secondary outcomes (4)
Change in ACR50
The change in American College of Rheumatology 50% (ACR50) compared to baseline
Measured: 12 weeks
Change in ACR70
The change in American College of Rheumatology 70% (ACR70) compared to baseline
Measured: 12 weeks
Change in (CDAI)
The change Clinical Disease Activity Index (CDAI) compared to baseline
Measured: 12 weeks
Change in DAS-28
The change in DAS-28, based on a CRP value, compare to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start26 Sep 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
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
- NCT05516979
- Sponsor's protocol ID
- SynAct-CS007
- Acronym
- EXPAND
- Status last verified
- Nov 2023
- First submitted
- 24 Aug 2022
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
- ClinicalTrials.gov ID
- NCT05516979
- Acronym / sponsor ID
- EXPAND / SynAct-CS007
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- SynAct Pharma ApsIndustry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 26 Aug 2022 (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 multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
| Arm | Type | Receives |
|---|---|---|
| 100 mg AP1189 | Experimental | Drug: 100 mg AP1189Treatment period of 12 weeks given as 1 tablet daily |
| Placebo | Placebo comparator | Drug: PlaceboTreatment period of 12 weeks given as 1 tablet daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 100 mg AP1189Also: AP1189 tablets for oral useAP1189 tablets for oral use | Drug | 100 mg AP1189 |
| PlaceboMatching placebo for oral use | Drug | Placebo |
Primary outcome
Number of reported AEs
Time frame: 12 weeks
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Change in ACR20
Time frame: 12 weeks
The change in American College of Rheumatology 20% (ACR20) compared to baseline
4 secondary outcomes
Change in ACR50
Time frame: 12 weeks
Change in ACR70
Time frame: 12 weeks
Change in (CDAI)
Time frame: 12 weeks
Change in DAS-28
Time frame: 12 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 7 Nov 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 100 mg AP1189 in people with Rheumatoid Arthritis, run by SynAct Pharma Aps at 1 site in Moldova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?
Number of reported AEs (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 7 Nov 2023.