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

NCT02475304 | Withdrawn Phase 2

• 1 other identifier: PSA-201-DMF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• ACR 20

  Weeks 8, 12, 28, 36, 40, 52

• BSA

  Weeks 8, 12, 24, 28, 36, 40, 52

• LEI

  Weeks 8, 12, 24, 28, 36, 40, 52

• ACR 50

  Weeks 8, 12, 24, 28, 36, 40, 52

• ACR 70

  Weeks 8, 12, 24, 28, 36, 40, 52

Study Arms (2)

Experimental FP187

EXPERIMENTAL

Treatment with a daily dose of 500mg FP187 (twice daily). Other names: Dimethyl fumarate

Drug: FP187

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

Interventions

FP187 DRUG

FP 187 is given as oral tablets twice daily, 500 mg daily

Also known as: Dimethyl Fumarate

Experimental FP187

Placebo DRUG

Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Department of Rheumatology, Skåne University Hospital

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Elke Theander, MD. PhD

  Skåne University Hospital, Lund University, 20502 Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior consultant Rheumatology, associate professor, PhD

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 18, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

SE (1)