A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects who Completed a Preceding Psoriasis Study With ABT-874

• Conditions: Moderate to severe chronic plaque psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-005955-40-BE
• Lead Sponsor: Abbott GmbH & Co. K.G.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Subjects who participated in a prior ABT-874 Phase 2 or Phase 3 study and who
did not prematurely discontinue the previous ABT-874 study (other than protocol
required discontinuation due to loss of response as defined in the original
ABT-874 protocol).
2. Males and females 18 years of age and over.
3. Women are eligible to participate in the study if they meet one of the following
criteria:
? Women of childbearing potential must undergo monthly pregnancy testing
during the study and agree to use two of the following methods of
contraception throughout the study and for 60 days after the last dose of study
drug:
? Oral contraceptives;
? Transdermal contraceptives;
? Injectable or implantable methods;
? Intrauterine devices;
Barrier methods (for example but not limited to a diaphragm with
spermicide, condom with spermicide) and
? Vasectomized partner
Subjects using oral or parenteral forms of contraceptives must have been
practicing birth control for at least three months prior to study drug
administration.
? Women who are postmenopausal (for at least one year), sterile, or
hysterectomized;
? Women who have undergone tubal ligation will be required to undergo
monthly pregnancy testing during the duration of the study and agree to use a
second form of contraception which includes:
? Oral contraceptives;
? Transdermal contraceptives;
? Injectable or implantable methods;
? Intrauterine devices;
? Barrier methods (for example but not limited to a diaphragm with
spermicide, condom with spermicide) and
? Vasectomized partner
? Sexual abstinence practiced throughout the study, defined as total abstinence
from sexual intercourse, is considered an adequate form of contraception
(agreement to comply with sexual abstinence must be recorded in the source
document and must be discussed with the Medical Monitor).
4. Sexually active male subjects from the M10-255 study (including males who have had a vasectomy) are eligible to participate in M10-016 if the continue to use effective contraception (i.e. condoms with spermicides) for 6 months after the last dose of study drug received in M10-255.
5. Subject is judged to be in good general health as determined by the Principal
Investigator (PI) based upon the results of medical history, laboratory profile, and
physical examination.
6. Able and willing to give written informed consent and to comply with the
requirements of this study protocol.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:
1. Subjects who prematurely discontinued in any preceding psoriasis study with
ABT-874 (other than protocol required discontinuation due to loss of response as
defined in the original ABT-874 protocol).
2. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication-exacerbated psoriasis, or new onset guttate
psoriasis.
3. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or
viral) that may interfere with evaluation of psoriasis.
4. History of an allergic reaction or significant sensitivity to constituents of study
drug.
5. Subject that must use topical therapies for the treatment of psoriasis such as
corticosteroids, vitamin D analogs, or retinoids during the study. Subjects are
allowed to use:
? Shampoos that contain no corticosteroid;
? Bland (without beta or alpha hydroxy acids) emollients;
? Low potency (Class VI or Class VII) topical corticosteroids on the palms,
soles, face, inframammary area, and groin only.
6. Cannot avoid UVB phototherapy during the study.
7. Cannot avoid PUVA phototherapy during the study.
8. Subject requires systemic therapies known to improve psoriasis, other than study
drug, during the study.
9. Subject is taking or requires oral or injectable corticosteroids for greater than 2 weeks during the study for other medical conditions, besides psoriasis.
Inhaled corticosteroids for stable medical conditions are allowed.
10. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, uncontrolled dyslipidemia, uncontrolled hypertension, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition, which, in the opinion of the Investigator and/or Abbott's Medical Monitor, would put the subject at risk by participation in the study.
11. Subject has infection or risk factors for severe infections, for example:
? Excessive immunosuppression or other factors associated with it, including
human immunodeficiency virus infection;
? Severe, recurrent, or persistent infections such as Hepatitis B or C;
? Active tuberculous disease;
? Subject will require vaccination with a live viral agent during the study.
12. History of malignancies other than successfully treated basal cell carcinoma, nonmetastatic
cutaneous squamous cell carcinoma or cervical carcinoma in situ.
13. History of major immunologic reaction (such as serum sickness or anaphylactoid
reaction) to an Immunoglobulin G containing agent (such as IV gamma globulin, a
fusion protein, or monoclonal antibody).
14. Female subject who is pregnant or breast-feeding or considering becoming
pregnant during the study or for 60 days after study completion.
15. Recent history of substance abuse or psychiatric illness that could preclude
compliance with the protocol.
16. For any reason, subject is considered by the Principal Investigator and/or Abbott's Medical Monitor to be an unsuitable candidate to receive ABT-874.
17. Subjects who meet 2 or more of the following 4 criteria and have not demonstrated failure to (i.e., failed to respond or lost response) or intolerance to other systemic therapies, including TNF inhibitor therapy at Week 0:
1. History of atherosclerotic cardiovascular disease as manifested by any of the following:
- Myocardial Infarction
- Stroke or transient ischemic attack
- Angina (car

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified