EUCTR2022-002605-26-BGActive, not recruitingPhase 1
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 - RESOLVE
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- SynAct Pharma ApS
- Enrollment
- 420
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria are the same for the Part A and the Part B population:
- •1. Written informed consent has been obtained prior to initiating any study specific
- •2. Male and female subjects, 18 to 85 years of age
- •3. Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification
- •criteria and ACR class I-III
- •a. = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on
- •68 joint counts)
- •b. Must meet at least one of the following parameters at Screening:
- •i. A positive result for anti-CCP or RF,
- •ii. Serum CRP = 6 mg/L based on central laboratory value
- •4. 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
- •5. Subject has an inadequate clinical response to maximally tolerated methotrexate
- •6. 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
- •7. Negative QuantiFERON-in-Tube test (QFG-IT) (Mantoux test can be used if QFGIT
- •is not possible)
- •8. Subjects should be able to complete (read and write) the Patient-Reported Outcome
- •questionnaires (PRO questionnaires)
- •9. Females of childbearing potential must have a negative pregnancy test at screening and again at baseline
- •10. Sexually active females 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 at least 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. If employing
- •birth control, each couple must use two of the following precautions: vasectomy,
- •tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth
- •control implant, birth control depot injections, condom with spermicide, or sponge
- •with spermicide.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
Exclusion Criteria
- •Exclusion criteria are the same for the Part A and the Part B populations:
- •1. Use of all other biologic or nonbiologic DMARDs and immunosuppressive therapy
- •within 4 weeks or five half-lives (whichever is longer) prior to administration of the
- •first dose of study drug
- •2. Oral steroids at a dose >10 mg/day of prednisone (or equivalent) or a prescription
- •for oral steroids which has changed within 4 weeks of baseline
- •3. Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks
- •prior to baseline
- •4. Participation in any other study involving investigational drug(s) within 4 weeks
- •prior to baseline
- •5. Major surgery (including joint operation) within 8 weeks prior to screening or
- •planned surgery within the period of the study participation
- •6. 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 (e.g., vasculitis,
- •pulmonary fibrosis or Felty’s syndrome). Sjögren’s syndrome with RA is allowable
- •7. Functional class IV as defined by the ACR Criteria for Classification of Functional
- •Status in RA or wheelchair/bedbound
- •8. Prior history of or current inflammatory joint disease other than RA (e.g., gout,
- •reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme
- •9. Subjects with fibromyalgia
- •10. Initiation or change in dose for NSAIDs (including low-dose aspirin and COX-2
- •inhibitors) within 2 weeks prior to baseline
- •11. Evidence of serious uncontrolled concomitant cardiovascular (including clinically
- •significantly prolonged QTc interval), nervous system, pulmonary (including
- •obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled
- •diabetes mellitus), or gastrointestinal disease
- •12. 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.
- •13. Prior renal transplant, current renal dialysis, or moderate to severe renal
- •insufficiency (determined by a derived glomerular filtration rate (GFR) using
- •Cockcroft Gault formula of =60 ml/min/1,73m²)
- •14. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel
- •disease where flares are commonly treated with oral or parenteral corticosteroids
- •15. Evidence of active malignant disease (except basal cell carcinoma of the skin that
- •has been excised and cured)
- •16. Pregnant women or nursing (breastfeeding) mothers
- •17. History of alcohol, drug, or chemical abuse within the 6 months prior to screening
- •18. Neuropathy or other painful, chronic conditions that might interfere with pain
- •19. Body weight of >150 kg
- •20. HBsAg positive and/or Anti-HBc with sign of current infection. Participants with
- •positive Anti-HBc should be tested for IgM anti-HBc - if IgM anti-HBc is positive
- •the patient will be excluded.
Investigators
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