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

NCT05604885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-11-06

No results posted yet for this study

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

Interventions

DRUG

AP1189, 60 mg

AP1189 tablets for oral use

DRUG

AP1189, 80 mg

AP1189 tablets for oral use

DRUG

AP1189, 100 mg

AP1189 tablets for oral use

DRUG

Placebo

Matching placebo tablets for oral use

Sponsors & Collaborators

  • NBCD A/S

    collaborator INDUSTRY

  • SynAct Pharma Aps

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-08-28
Completion
2023-08-28
FDA Drug
Yes

Countries

  • Moldova

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604885 on ClinicalTrials.gov