A Phase 2, Multicenter Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197

• Register: ClinicalTrials.gov
• Last refreshed on: 27 June 2016
• Main ID: NCT02429895
• Date of registration: 24/04/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Phase 2, Multicenter Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197
• Scientific title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT)
• Date of first enrolment: October 2015
• Target sample size: 168
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02429895
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Czech Republic, Germany, Hungary, Latvia, New Zealand, Poland, Romania, Spain

Contacts

• Name: Heikki T Mansikka, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not
developed any discontinuation criteria of Study M14-197.

2. If female, subject must meet one of the following criteria:

- Postmenopausal (defined as no menses for at least 1 year).

- Surgically sterile (bilateral oophorectomy or hysterectomy)

If subject does not meet one of the above two categories, subject must use one of the
following methods of birth control, from the time of the first dose of study drug
until 150 days after the last dose of study drug:

- Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation started at least 2 months prior to the first dose
of study drug: oral, intravaginal or transdermal

- Progestogen-only hormonal contraception associated with inhibition of ovulation
started at least two months prior to randomization: oral, injectable, or
implantable

- Intrauterine device (IUD)

- Intrauterine hormone-releasing system (IUS)

- Bilateral tubal occlusion/ligation

- Be with a vasectomized partner (procedure at least 6 months earlier, the
vasectomized male partner should be your sole partner)

- Sexual abstinence (refraining from heterosexual intercourse during the entire
study period)

3. If male, subject must be surgically sterile (have had a vasectomy more than 6 months
prior to Screening) or must be practicing at least 1 of the following methods of
birth control from the time of the first dose of study drug until 150 days post last
dose of study drug:

- Subject using condom and female partner(s) using an intrauterine device (IUD);

- Subject using condom and female partner(s) using hormonal contraceptives (oral,
vaginal, parenteral or transdermal);

- Subject using condom and female partner(s) using double-barrier method
(contraceptive sponge; diaphragm or vaginal ring with spermicidal jellies,
creams, or spermicide);

- Total abstinence from sexual intercourse as the preferred lifestyle of the
subject; periodic abstinence is not acceptable.

- Subject must also agree to not donate sperm starting on the first day of study
drug administration until 150 days after the last dose of study drug.

4. Subjects must voluntarily sign and date an informed consent, approved by an
Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the
initiation of any study-specific procedures.

5. Subject is judged to be in good health as determined by the Investigator.

Exclusion Criteria:

1. Pregnant or breastfeeding or plans to become pregnant during study participation.

2. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within
14 days.

3. Anticipated requirement or receipt of any live vaccine during study participation
including up to 120 days after the last dose of study drug.

4. Current enrollment in another investigational study; with the exception of Study
M14-197, which is required.

5. Consideration by the Investigator, for any reason, that the subject is an unsuitable
candidate to continue to receive ABT-122.



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

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: ABT-122

Primary Outcome(s)

Change in Psoriatic Disease Activity Score (PASDAS) by visit [Time Frame: From Week 0 to Week 24]

Change in Disease Activity Score DAS28 [hsCRP] by visit [Time Frame: From Week 0 to Week 24]

Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit [Time Frame: From Week 0 to Week 24]

American College of Rheumatology (ACR) 50 response rate by visit [Time Frame: From Week 0 to Week 24]

American College of Rheumatology (ACR) 70 response rate by visit [Time Frame: From Week 0 to Week 24]

Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit [Time Frame: From Week 0 to Week 24]

Change in American College of Rheumatology (ACR) the individual component by visit [Time Frame: From Week 0 to Week 24]

Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit [Time Frame: From Week 0 to Week 24]

Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit [Time Frame: From Week 0 to Week 24]

American College of Rheumatology (ACR) 20 response rate by visit [Time Frame: From Week 0 to Week 24]

Change in skin biopsy/biomarkers [Time Frame: From Week 0 to Week 24]

Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit [Time Frame: From Week 0 to Week 24]

Change in Psoriasis Target Lesion Score by visit [Time Frame: From Week 0 to Week 24]

Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit [Time Frame: From Week 0 to Week 24]

Change in Dactylitis Assessment by visit [Time Frame: From Week 0 to Week 24]

Change in Psoriasis Area and Severity Index (PASI) by visit [Time Frame: From Week 0 to Week 24]

Secondary ID(s)

2014-005527-27

M14-198

Source(s) of Monetary Support

Please refer to primary and secondary sponsors