A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 6 December 2021
• Main ID: NCT04004429
• Date of registration: 26/06/2019
• Prospective Registration: Yes
• Primary sponsor: SynAct Pharma Aps
• Public title: A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease SynAct-CS002
• Scientific title: A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease
• Date of first enrolment: August 26, 2019
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04004429
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Denmark, Norway

Contacts

• Name: Ellen-Margrethe Hauge, Professor
• Affiliation: Aarhus Universitetshospital

• Name: Espen A Haavardsholm, Concultant, PhD
• Affiliation: Diakonhjemmet Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent has been obtained prior to initiating any study specific
procedures

- Male and female subjects, 18 to 85 years of age

- Confirmed diagnosis of (RA) Rheumatoid Arthritis according to the 2010 ACR/EULAR RA
classification criteria

- Polyarthritis with joint swelling and tenderness of a minimum of three joints out of
68 joints tested

- Candidate for Methotrexate treatment

- Is about to begin treatment with MTX (Methotrexate)

- Tested positive for anti-CCP Anti-cyclic citrullinated peptide) or RF (Rheumatoid
Factor)

- Severe active RA (CDAI > 22) at screening and baseline

- Negative QFG-IT (QuantiFERON-in-Tube test)

- Subjects should be able to complete the PRO (Patient Reported Outcome) questionnaires

- Females of child-bearing potential may only participate if using reliable means of
contraception or are post-menopausal. Surgically sterilized women at least 6 months
prior to screening

- Females of childbearing potential must have a negative pregnancy test at screening and
baseline

Exclusion Criteria:

- Participation in any other study involving investigational drug(s) within 4 weeks
prior to study entry

- Major surgery within 8 weeks prior to screening or planned surgery within 1 month
following randomization

- Rheumatic autoimmune disease other than RA, including SLE (systemic Lupus
Erythematosus), MCTD (Mixed Connective Tissue Disease), scleroderma, polymyositis, or
significant systemic involvement secondary to RA. Sjögren syndrome with RA is
allowable

- 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 within 2 weeks prior to dosing with the IMP
(Investigational Medicinal Product)

- Corticosteroids are prohibited within 2 weeks prior to screening (and during the
entire treatment period and until the final visit

- 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
(determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault
Formula of =30 mL/min/1,73 m2 calculated by the local lab)

- 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

- Pregnant women or nursing mothers

- History of alcohol, drug, or chemical abuse within the 6 months prior to screening

- Neuropathies or other painful conditions that might interfere with pain evaluation

- Body weight of >150 kg

Exclusion criteria that only applies for Norway

- Evidence of moderate and/or severe organ dysfunction

- Abnormal chest x-ray (as per the discretion of the investigator

- Evidence of positive hepatitis serology

- Evidence of peptic ulcer disease



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: AP1189

Drug: Placebo

Drug: 50 mg AP1189

Primary Outcome(s)

Change in CDAI [Time Frame: 4 weeks]

Secondary Outcome(s)

DAS28 score [Time Frame: 4 weeks]

ACR (American College of Rheumatology) response [Time Frame: 4 weeks]

CDAI score [Time Frame: 4 weeks]

FACIT-Fatigue questionnaire [Time Frame: 4 weeks]

Swollen and tender joints [Time Frame: 4 weeks]

HAQ-DI (Health Assessment Questionnaire-Disability Index) questionnaire [Time Frame: 4 weeks]

Secondary ID(s)

SynAct-CS002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors