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

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)

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).

Study Overview

• Status: Terminated
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: ABT-122

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Woolloongabba, Australia, 4102
    • Site Reference ID/Investigator# 138922
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Site Reference ID/Investigator# 138925
  • Plovdiv, Bulgaria, 4002
    • Site Reference ID/Investigator# 138926
  • Plovdiv, Bulgaria, 4003
    • Site Reference ID/Investigator# 138927
  • Sofia, Bulgaria, 1463
    • Site Reference ID/Investigator# 138928
  • Sofia, Bulgaria, 1463
    • Site Reference ID/Investigator# 138930
  • Sofia, Bulgaria, 1505
    • Site Reference ID/Investigator# 138929
• Czech Republic
  • Praha, Czech Republic, 150 06
    • Site Reference ID/Investigator# 138933
  • Praha 4, Czech Republic, 140 00
    • Site Reference ID/Investigator# 138934
  • Uherske Hradiste, Czech Republic, 68601
    • Site Reference ID/Investigator# 138932
• Germany
  • Frankfurt, Germany, 60528
    • Site Reference ID/Investigator# 141365
  • Luebeck, Germany, 23538
    • Site Reference ID/Investigator# 138953
• Hungary
  • Budapest, Hungary, 1027
    • Site Reference ID/Investigator# 138959
• Latvia
  • Adazi, Latvia, LV-2164
    • Site Reference ID/Investigator# 138983
  • Riga, Latvia, LV-1012
    • Site Reference ID/Investigator# 138985
  • Riga, Latvia, LV1011
    • Site Reference ID/Investigator# 138982
  • Valmiera, Latvia, LV-4201
    • Site Reference ID/Investigator# 138984
• New Zealand
  • Auckland, New Zealand, 2025
    • Site Reference ID/Investigator# 138986
  • Nelson, New Zealand, 7010
    • Site Reference ID/Investigator# 138988
  • Newtown, Wellington, New Zealand, 6021
    • Site Reference ID/Investigator# 138987
• Poland
  • Bialystok, Poland, 15-879
    • Site Reference ID/Investigator# 139000
  • Bydgoszcz, Poland, 85-168
    • Site Reference ID/Investigator# 139012
  • Elblag, Poland, 82-300
    • Site Reference ID/Investigator# 138999
  • Katowice, Poland, 40-748
    • Site Reference ID/Investigator# 139007
  • Krakow, Poland, 31-637
    • Site Reference ID/Investigator# 139006
  • Lublin, Poland, 20-582
    • Site Reference ID/Investigator# 139005
  • Oswiecim, Poland, 32-600
    • Site Reference ID/Investigator# 139026
  • Poznan, Poland, 60-218
    • Site Reference ID/Investigator# 139004
  • Stalowa Wola, Poland, 37-450
    • Site Reference ID/Investigator# 139001
  • Szczecin, Poland, 70-332
    • Site Reference ID/Investigator# 139011
  • Torun, Poland, 87-100
    • Site Reference ID/Investigator# 139003
  • Wroclaw, Poland, 51-685
    • Site Reference ID/Investigator# 139010
• Romania
  • Bucuresti, Romania, 011172
    • Site Reference ID/Investigator# 139013
  • Targu-Mures, Jud. Mures, Romania, 540136
    • Site Reference ID/Investigator# 139016
• Spain
  • Elche, Spain, 03203
    • Site Reference ID/Investigator# 139022
  • Santiago de Compostela, Spain, 15702
    • Site Reference ID/Investigator# 139020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: All subjects (open-label extension); All subjects will start treatment with ABT-122	Drug: ABT-122; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American College of Rheumatology (ACR) 20 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24
American College of Rheumatology (ACR) 50 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24
American College of Rheumatology (ACR) 70 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24
Change in American College of Rheumatology (ACR) the individual component by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24
Change in Disease Activity Score DAS28 [hsCRP] by visit	Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.	From Week 0 to Week 24
Change in Psoriatic Disease Activity Score (PASDAS) by visit	PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.	From Week 0 to Week 24
Change in Psoriasis Area and Severity Index (PASI) by visit	Determined by scores for the amount and severity of a patient's psoriasis.	From Week 0 to Week 24
Change in Psoriasis Target Lesion Score by visit	Determined by plaque erythema, plaque scaling and plaque thickness scores.	From Week 0 to Week 24
Change in Dactylitis Assessment by visit	Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.	From Week 0 to Week 24
Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit	Determined by the presence and severity of enthesitis.	From Week 0 to Week 24
Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit	Determined by scores given by patients regarding the severity of their psoriatic symptoms.	From Week 0 to Week 24
Change in skin biopsy/biomarkers	Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.	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	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	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	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	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	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24
Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Heikki T Mansikka, MD, AbbVie

Publications and helpful links

General Publications

• Genovese MC, Weinblatt ME, Mease PJ, Aelion JA, Peloso PM, Chen K, Li Y, Liu J, Othman AA, Khatri A, Mansikka HT, Leszczynski P. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis. Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 10.1093/rheumatology/key173.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (ESTIMATE): April 29, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Methotrexate; Efficacy
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: M14-198; 2014-005527-27 (EUDRACT_NUMBER)