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

NCT05604885 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SynAct-CS006
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Part A: Change in ACR20

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

  4 weeks

• Part B: Change in ACR20

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

  12 weeks

• 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

  12 weeks

Secondary Outcomes (8)

• Part A: Change in ACR50

  4 weeks

• Part B: Change in ACR50

  12 weeks

• Part A: Change in ACR70

  4 weeks

• Part B: Change in ACR70

  12 weeks

• Part A: Change in CDAI

  4 weeks

Study Arms (4)

AP1189, 60 mg

EXPERIMENTAL

Part A: (AP1189, 60 mg); Part B: (TBD)

Drug: AP1189, 60 mg

AP1189, 80 mg

EXPERIMENTAL

Part A: (AP1189, 80 mg); Part B: (TBD)

Drug: AP1189, 80 mg

AP1189, 100 mg

EXPERIMENTAL

Part A: (AP1189, 100 mg); Part B: (TBD)

Drug: AP1189, 100 mg

Placebo

PLACEBO COMPARATOR

Part A: (placebo); Part B: (placebo).

Drug: Placebo

Interventions

AP1189, 60 mg DRUG

AP1189 tablets for oral use

AP1189, 60 mg

AP1189, 80 mg DRUG

AP1189 tablets for oral use

AP1189, 80 mg

AP1189, 100 mg DRUG

AP1189 tablets for oral use

AP1189, 100 mg

Placebo DRUG

Matching placebo tablets for oral use

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• SynAct Pharma Aps: lead
• NBCD A/S: collaborator

Study Sites (1)

Timofei Mosneaga Republican Clinical Hospital

Chisinau, Moldova

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

N-(3-(1-(2-nitrophenyl)-1H-pyrrol-2-yl)allylidenamino)guanidine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, two-part, randomized, double-blind, placebo-controlled study 4 and 12 weeks study with repeated doses of AP1189

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 3, 2022
• Study Start: November 30, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)