A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment

Rheumatoid Arthritis Clinical Trial

— EXPAND  

Official title:

A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516979
• Other study ID #: SynAct-CS007
• Status: Completed
• Phase: Phase 2
• Start date: September 26, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: November 2023
• Source: SynAct Pharma Aps
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Main 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).
• Candidate for MTX treatment
• Is about to begin treatment with MTX
• Must meet at least one of the following parameters at Screening:

1. positive result for anti-CCP or RF

2. Serum CRP = 6 mg/L

• Highly active RA (CDAI > 22) at screening and baseline
• Negative QuantiFERON-in-Tube test (QFG-IT)
• Females of child-bearing potential must use of highly effective birth control method

Main Exclusion Criteria:

• Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
• 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. Sjögren's syndrome with RA is allowable
• Prior history of or current inflammatory joint disease other than RA
• Subjects with fibromyalgia
• Use of hydroxychloroquine within 4 weeks prior the Screening Visit
• Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
• Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
• 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)
• Neuropathies or other painful conditions that might interfere with pain evaluation
• Body weight of >150 kg
• HBsAg positive and/or Anti-HBc with sign of current infection.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 100 mg AP1189
AP1189 tablets for oral use
• Placebo
Matching placebo for oral use

Locations

Country	Name	City	State
Moldova, Republic of	Timofei Mosneaga Republican Clinical Hospital	Chi?inau

Sponsors (2)

Lead Sponsor	Collaborator
SynAct Pharma Aps	NBCD A/S

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reported AEs	Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo	12 weeks
Primary	Change in ACR20	The change in American College of Rheumatology 20% (ACR20) compared to baseline	12 weeks
Secondary	Change in ACR50	The change in American College of Rheumatology 50% (ACR50) compared to baseline	12 weeks
Secondary	Change in ACR70	The change in American College of Rheumatology 70% (ACR70) compared to baseline	12 weeks
Secondary	Change in (CDAI)	The change Clinical Disease Activity Index (CDAI) compared to baseline	12 weeks
Secondary	Change in DAS-28	The change in DAS-28, based on a CRP value, compare to baseline	12 weeks