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

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SynAct Pharma Aps
• Collaborator: NBCD A/S

Criteria

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)

• Must meet at least one of the following parameters at Screening:

1. A positive result for anti-CCP or RF,

2. 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

• 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

Exclusion Criteria:

• 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

• 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 COX-2 inhibitors) within 2 weeks prior to baseline

• 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)

• 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.