Proof-of-concept Study of Forward Pharma (FP)187 in Patients With Mild/Moderate Psoriatic Arthritis

A Randomized, Double Blind, Placebo-controlled Proof-of-concept Study of FP187 in Patients With Mild to Moderate Psoriatic Arthritis

The purpose of this study is to investigate, whether FP187 is effective in the treatment of mild to moderate psoriatic arthritis.

Study Overview

• Status: Withdrawn
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: FP187

Detailed Description

The study is randomised, double blind, placebo-controlled proof-of-concept trial to investigate the efficacy and safety of FP187 compared to placebo over 24 weeks of treatment in patients with mild to moderate psoriatic arthritis (PsA). The daily dose levels in the FP187 arm will be 500 mg. After completion of the double blind treatment of 24 weeks, all patients irrespective of their treatment arm will be switched to an additional 24 week open-label treatment phase with 500 mg / day FP187. Patient who do not complete the 24 week double blind part of the study as scheduled will not be eligible for participation in the open-label part.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Department of Rheumatology, Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• documented clinical diagnosis of mild to moderate psoriatic arthritis of at least 3 months
• active psoriatic arthritis with at least 2 tender and 2 swollen joints
• signed informed consent
• willingness and ability to comply with study procedures
• besides psoriatic arthritis, patient must be in good general health in the opinion of the investigator, as determined by medical history, physical examination, vital signs, electrocardiography and clinical laboratory parameters
• if patients are using methotrexate, they should be on a stable dosis of not more the 20mg per week for at least 90 days prior to study entrance and should present no serious toxic side effects attributable to methotrexate
• female of childbearing age must be either surgically sterile or use a highly effective medically accepted contraceptive method

Exclusion Criteria:

• female patients who are pregnant of breast-feeding or planning to become pregnant during the entire trial period
• male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period
• known allergy to any of the constituents of the products being tested
• known immunosuppressive diseases (e.g. HIV, AIDS)
• known history of latent or active granulomatous infection including tuberculosis, histoplasmosis or coccidioidomycosis
• presence of another inflammatory disease including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematous or Lyme disease
• presence of chronic widespread pain syndrome
• patients with pustular forms of psoriasis, erythrodermic or guttate psoriasis
• patients with another non-psoriatic arthropathy (e.g. osteoarthritis)
• presence of another serious or progressive disease including skin malignancy
• presence or history of any malignancy (except for basal cell carcinoma, squamous cell carcinoma in situ of the skin treated with no evidence of recurrence within 5 years, or cervix cancer in situ treated with no evidence of recurrence.)
• use at any time of an biological Disease Modifying Antirheumatic Drug (bDMARD) such as etanercept, adalimumab, golimumab, certolizumab pegol or infliximab
• corticosteroid injections within 12 weeks
• use of any dimethyl fumarate (DMF) containing product within 12 weeks
• use of any retinoid treatments, other immunosuppressive treatments, cytostatics or drugs with known harmful effects on the kidneys within the last 3 months
• use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks
• ongoing stomach or intestinal problems (e.g. gastritis or peptic ulcer)
• Aspartate transaminase (AST) or Alanine transaminase (ALT) > 2x upper normal normal limit (UNL) or Gamma Glutamyl Transferase (gamma-GT) results >2.5 UNL
• estimated creatinine clearance (Cockcroft-Gault) < 60ml/min
• leucopenia (leucocyte count < 3.5/nl), eosinophilia (>750 / micro l) or lymphocytopenia (<1.02 / nl)
• protein detected by urine stick test
• participation in another clinical trial during the last 2 months or participation in a trial with another psoriatic arthritis treatment within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental FP187; Treatment with a daily dose of 500mg FP187 (twice daily). Other names: Dimethyl fumarate	Drug: FP187; FP 187 is given as oral tablets twice daily, 500 mg daily; Other Names: Dimethyl Fumarate
Placebo Comparator: Placebo Comparator; Patients will receive the same number of tablets as patients randomized to FP187 arm in order to maintain the blind. The colour and shape of the FP187 and placebo tablets will be the same so that no visible difference is detectable	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Congress of Rheumatology (ACR)20	Proportion of patients with a 20% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR 20	Proportion of patients with a 20% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.	Weeks 8, 12, 28, 36, 40, 52
BSA	Body Surface Area (BSA) affected by psoriasis	Weeks 8, 12, 24, 28, 36, 40, 52
LEI	Change from baseline in the Leeds Enthesitis Index (LEI)	Weeks 8, 12, 24, 28, 36, 40, 52
ACR 50	Proportion of patients with a 50% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.	Weeks 8, 12, 24, 28, 36, 40, 52
ACR 70	Proportion of patients with a 70% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.	Weeks 8, 12, 24, 28, 36, 40, 52
Pain	Change from baseline in Pain Visual Analogue Scale (VAS) score	Weeks 8, 12, 24, 28, 36, 40, 52
EQ-5D	Change from baseline in European Quality of Life - 5 Dimensions (EQ-5D) score	Weeks 8, 12, 24, 28, 36, 40, 52
BASDAI	Change from baseline in Bath Ankylosing Spondylitis Disease Activity (BASDAI) score	Weeks 8, 12, 24, 28, 36, 40, 52
BASFI	Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score	Weeks 8, 12, 24, 28, 36, 40, 52
HAQ	Change from baseline in Health Assessment Questionnaire (HAQ) score	Weeks 8, 12, 24, 28, 36, 40, 52

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Investigators: Principal Investigator: Elke Theander, MD. PhD, Skåne University Hospital, Lund University, 20502 Malmö, Sweden

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: May 31, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: PSA-201-DMF