A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02349451
• Date of registration: 23/01/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
• Scientific title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate
• Date of first enrolment: April 28, 2015
• Target sample size: 240
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02349451
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Latvia, New Zealand, Poland, Romania, Spain, United States

Contacts

• Name: Paul Peloso, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- PsA diagnosis of at least 3 months duration prior to the date of first screening with
ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.

- Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas
other than the axilla or groin.

- Have active arthritis defined by minimum disease activity criteria:

1. >= 3 swollen joints (based on 66 joint counts) at Screening

2. >= 3 tender joints (based on 68 joint counts) at Screening

- On a stable dose of methotrexate (MTX) defined as:

1. Oral or parenteral treatment >= 3 months

2. On a stable dose with an unchanged mode of application for at least 4 weeks prior
to baseline

3. Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable
approved local label

4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs,
sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

Exclusion Criteria:

- Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be
enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety
concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior
to the Baseline visit.

- Subjects on prior adalimumab may not be enrolled in the study

- Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic
drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of
these drugs prior to the baseline visit.

- Current treatment with traditional oral/intramuscular DMARDs, including conventional
synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or
hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5
half-lives of a drug apart from MTX prior to the Baseline visit.

a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase
type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5
half-lives.

- Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within
the 30 days of the Baseline visit.

- Intra-articular or parenteral administration of corticosteroids in the preceding 4
weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are
allowed.

- Laboratory values of the following at the Screening Visit:

1. Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females

2. Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of
African descent who are black)

3. Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of
normal (ULN) or bilirubin >= 3 mg/dL

4. Serum creatinine > 1.5 x the ULN

5. Platelets < 100,000 cells/[mm^3] (10^9/L),

6. Clinically significant abnormal screening laboratory results as evaluated by the
Investigator



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Biological: ABT-122

Biological: adalimumab

Primary Outcome(s)

American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Psoriasis Target Lesion Score at Week 12 [Time Frame: Baseline, Week 12]

ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab [Time Frame: Week 12]

ACRn at Week 12 [Time Frame: At Week 12]

Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12 [Time Frame: Baseline, Week 12]

ACR70 Response Rate at Week 12 [Time Frame: Week 12]

ACR50 Response Rate at Week 12 [Time Frame: Week 12]

Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12 [Time Frame: Baseline, Week 12]

Secondary ID(s)

M14-197

2014-003558-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02349451