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. - ND
- Conditions
- Moderate to severe chronic plaque psoriasisMedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis
- Registration Number
- EUCTR2007-005955-40-IT
- Lead Sponsor
- Abbott GmbH & Co. K. G.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
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; and ○ Barrier methods (diaphragm with spermicide, condom with spermicide). 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; and ○ Barrier methods (diaphragm with spermicide, or condom with spermicide). ● 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. 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. 5. 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
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 during the study. Inhaled corticosteroids for stable medical conditions are allowed. 10. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method