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)

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2014-005527-27-CZ
• Date of registration: 28/04/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• 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 Phase 2 Randomized Controlled Trial (RCT)
• 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: 12/08/2015
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005527-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

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, defined in Section 5.4.1 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, with no alternate cause for amenorrhea).
? 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 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 after the 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);
? 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 laast 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 based on the results of medical history, physical examination and laboratory profile performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis
MedDRA version: 18.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: ABT-122
Product Code: ABT-122
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: na
Other descriptive name: ABT-122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: -To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122.
-To explore the longer term effects of ABT-122 on function, quality of life and fatigue.

Main Objective: Assess the long term efficacy, and safety and tolerability of ABT-122 in psoriatic arthritis (PsA) subjects on background methotrexate (MTX) who have completed Study M14-197 Phase 2 RCT.

Primary end point(s): The primary objective of Study M14-198 is to assess the long term efficacy, and the safety and tolerability of ABT-122 in PsA subjects on background methotrexate (MTX) who have completed Study M14-197 Phase2 RCT.

Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24

Secondary end point(s): ? To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122.
? To explore the longer term effects of ABT-122 on function, quality of life and fatigue.

Secondary ID(s)

M14-198

2014-005527-27-HU

Source(s) of Monetary Support

Abbvie Inc