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

NCT05516979 | Completed Phase 2

• 1 other identifier: SynAct-CS007
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• Change in ACR20

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

  12 weeks

Secondary Outcomes (4)

• Change in ACR50

  12 weeks

• Change in ACR70

  12 weeks

• Change in (CDAI)

  12 weeks

• Change in DAS-28

  12 weeks

Study Arms (2)

100 mg AP1189

EXPERIMENTAL

Treatment period of 12 weeks given as 1 tablet daily

Drug: 100 mg AP1189

Placebo

PLACEBO COMPARATOR

Treatment period of 12 weeks given as 1 tablet daily

Drug: Placebo

Interventions

100 mg AP1189 DRUG

AP1189 tablets for oral use

Also known as: AP1189 tablets for oral use

100 mg AP1189

Placebo DRUG

Matching placebo 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).
• Candidate for MTX treatment
• Is about to begin treatment with MTX
• Must meet at least one of the following parameters at Screening:
• positive result for anti-CCP or RF
• 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

You may not qualify if:

• 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.

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, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 26, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)