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Rheumatoid ArthritisPhase 2RESOLVENCT05604885

A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

A Phase 2 study testing AP1189, 60 mg, AP1189, 80 mg and AP1189, 100 mg in people with Rheumatoid Arthritis, run by SynAct Pharma Aps at 1 site in Moldova.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult RA patients with an inadequate response to MTX alone. 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?
AP1189, 60 mg, AP1189, 80 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
125 participants
Where
1 siteMoldova
Study dates
30 Nov 2022to 28 Aug 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

Who may be able to join

  • 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)
  • Must meet at least one of the following parameters at Screening:
  • A positive result for Anti-Cyclic Citrullinated Peptide (anti-CCP) or Rheumatoid Factor (RF),
  • Serum CRP ≥ 6 mg/L based on central laboratory value
  • Ongoing methotrexate therapy ≥12 weeks in a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to the baseline visit
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  • Subject has an inadequate clinical response to maximally tolerated methotrexate therapy
  • Subjects should be receiving an adequate and prescribed stable dose of folic acid (≥5 mg/week total dose or as per local clinical practice) which should be confirmed or initiated at screening and continued throughout the study
  • Negative QuantiFERON-in-Tube test (QFG-IT)
  • Females of child-bearing potential must use of highly effective birth control method
  • Male participant's partner must use highly effective birth control

Who cannot join

  • Use of all other biologic or nonbiologic DMARDs and immunosuppressive therapy within 4 weeks prior to administration of the first dose of study drug
  • Oral steroids at a dose >10 mg/day of prednisone or a prescription for oral steroids which has changed within 4 weeks of baseline
  • Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to baseline
  • Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within the period of the study participation
  • Rheumatic autoimmune disease other than RA
  • Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound
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  • Prior history of or current inflammatory joint disease other than RA
  • Subjects with fibromyalgia
  • Initiation or change in dose for NSAIDs (including low-dose aspirin and Cyclooxygenase (COX-2) inhibitors) within 2 weeks prior to baseline
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
  • Serum Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 1.5 x the upper limit of normal (ULN) and alkaline phosphatase (ALP) and/or bilirubin values above the ULN at the screening visit
  • Have prior renal transplant, current renal dialysis, or moderate to 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)
  • History of alcohol, drug, or chemical abuse within the 6 months prior to screening
  • Neuropathy or other painful, chronic 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.

Moldova1 site

  • Timofei Mosneaga Republican Clinical Hospital

    Chisinau

Other trials in Moldova

About this study

Official title: A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE)

The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult RA patients with an inadequate response to MTX alone.

Read the detailed description

In Part A approximately 120 randomized patients will be treated with either 60 mg AP1189, 80 mg AP1189, 100 mg AP1189 or placebo once daily for 4 weeks as add-on treatment to stable MTX treatment. Part A will conclude with an unblinded assessment for risk/benefit and a recommendation for dose selection for Part B.

In Part B patients will be randomized into groups of equal size evaluating 2-3 doses of AP1189 versus placebo. All doses will be administered once daily for 12 weeks as add-on treatment to stable MTX treatment. The proposed sample size per dose group/placebo group is 75 patients, by which the total study population of Part B may be either 225 or 300 patients, depending on the number of dose groups of AP1189 selected for evaluation based on Part A.

Being tested
AP1189, 60 mg, AP1189, 80 mg, AP1189, 100 mg, 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, 60 mgDrug

    AP1189 tablets for oral use

  • AP1189, 80 mgDrug

    AP1189 tablets for oral use

  • AP1189, 100 mgDrug

    AP1189 tablets for oral use

  • PlaceboDrug

    Matching placebo tablets for oral use

Study groups in NCT05604885
Study groupRoleWhat they receive
AP1189, 60 mgExperimentalPart A: (AP1189, 60 mg); Part B: (TBD)
Receives: Drug: AP1189, 60 mg
AP1189, 80 mgExperimentalPart A: (AP1189, 80 mg); Part B: (TBD)
Receives: Drug: AP1189, 80 mg
AP1189, 100 mgExperimentalPart A: (AP1189, 100 mg); Part B: (TBD)
Receives: Drug: AP1189, 100 mg
PlaceboPlacebo comparatorPart A: (placebo); Part B: (placebo).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Change in ACR20

    The change in American College of Rheumatology 20% (ACR20) compared to baseline

    Measured: 4 weeks

  2. Part B: Change in ACR20

    The change in American College of Rheumatology 20% (ACR20) compared to baseline

    Measured: 12 weeks

  3. Number of reported Adverse Events

    Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo

    Measured: 12 weeks

Secondary outcomes (8)

  1. Part A: Change in ACR50

    The change in American College of Rheumatology 50% (ACR50) compared to baseline

    Measured: 4 weeks

  2. Part B: Change in ACR50

    The change in American College of Rheumatology 50% (ACR50) compared to baseline

    Measured: 12 weeks

  3. Part A: Change in ACR70

    The change in American College of Rheumatology 70% (ACR70) compared to baseline

    Measured: 4 weeks

  4. Part B: Change in ACR70

    The change in American College of Rheumatology 70% (ACR70) compared to baseline

    Measured: 12 weeks

  5. Part A: Change in CDAI

    The change Clinical Disease Activity Index (CDAI) compared to baseline

    Measured: 4 weeks

  6. Part B: Change in CDAI

    The change Clinical Disease Activity Index (CDAI) compared to baseline

    Measured: 12 weeks

  7. Part A: Change in DAS-28

    The change in Disease Activity Score (DAS-28), based on a C-Reactive Protein (CRP) value, compare to baseline

    Measured: 4 weeks

  8. Part B: Change in DAS-28

    The change in Disease Activity Score (DAS-28), based on a C-Reactive Protein (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.

  1. First posted3 Nov 2022
  2. Study start30 Nov 2022
  3. Primary completion28 Aug 2023
  4. Study completion28 Aug 2023

Resources

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, two-part, randomized, double-blind, placebo-controlled study 4 and 12 weeks study with repeated doses of AP1189
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05604885
Sponsor's protocol ID
SynAct-CS006
Acronym
RESOLVE
Status last verified
Nov 2024
First submitted
31 Oct 2022
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AP1189, 60 mg, AP1189, 80 mg and AP1189, 100 mg 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?

The sponsor lists 11 inclusion and 18 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 6 Nov 2024. 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?

Part A: Change in ACR20 (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05604885.

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 Nov 2024.

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