Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Filgotinib — DRUG
  Tablets administered orally once daily with or without food
• Adalimumab — DRUG
  Injection administered subcutaneously once every 2 weeks
• Placebo to match filgotinib — DRUG
  Tablets administered orally once daily with or without food
• Placebo to match adalimumab — DRUG
  Injection administered subcutaneously once every 2 weeks

Study Details

The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).

Key Dates

Start date

Dec 3, 2019

Status verified

Apr 2022

Primary completion

Jan 19, 2021

Completion

May 11, 2021

Study Design

Enrollment

67 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Filgotinib 200 mg (Main Study)
  Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
• Experimental: Filgotinib 100 mg (Main Study)
  Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg + PTM adalimumab for up to 16 weeks.
• Active Comparator: Adalimumab (Main Study)
  Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + adalimumab 40 mg injection for up to 16 weeks.
• Placebo Comparator: Placebo (Main Study)
  Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
• Experimental: Filgotinib 200 mg (Long Term Extension [LTE])
  Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 34 weeks.
• Experimental: Filgotinib 100 mg (LTE)
  Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 34 weeks.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 [ Time Frame: Week 12 ]

Locations (24)

Find similar trials in Covina, CA

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