Moderate to severe chronic plaque psoriasis MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: ABT-874
Product Code: ABT-874
Pharmaceutical Form: Solution for injection
INN or Proposed INN: None
CAS Number: 339308-60-0
Current Sponsor code: ABT-874
Other descriptive name: J695, B
Sponsors
Abbott GmbH & Co. K.G.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 years of age and over. 2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the Principal Investigator. 3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) visits as determined by subject interview of his/her medical history. 4. Moderate to severe plaque psoriasis defined by = 10% Body Surface Area (BSA) involvement at the Baseline (Week 0) visit. 5. PGA of at least moderate disease (defined as PGA = 3) at the Baseline (Week 0) visit. 6. PASI score of = 12 at the Baseline (Week 0) visit. 7. Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents. 8. 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 6 months 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). 9. Sexually active male subjects (including males who have had a vasectomy) are able to participate in the study if they use effective contraception (i.e. condoms with spermicide) during the study and 6 months after study completion. 10. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening. 11. 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
Exclusion criteria: 1. Previous exposure to systemic anti-IL-12 therapy, including ABT-874. 2. Subject has previous exposure to MTX. 3. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. 4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. 5. History of an allergic reaction or significant sensitivity to constituents of study drug (See Section 5.5.2 of the study protocol). 6. Cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 2 weeks prior to the Baseline (Week 0) visit and 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. See Appendix O for a listing of examples of Class VI or VII topical corticosteroids. 7. Cannot avoid UVB phototherapy for at least 2 weeks prior to the Baseline (Week 0) visit and during the study. 8. Cannot avoid PUVA phototherapy for at least 4 weeks prior to the Baseline (Week 0) visit and during the study. 9. Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study. See study protocol for further details. 10. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. 11. 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 or Medical Monitor, would put the subject at risk by participation in the study. 12. Subject has a history of clinically significant hematologic (e.g. severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g. fibrosis, cirrhosis, hepatitis). 13. 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; ? Evidence of latent tuberculosis (TB) infection demonstrated by Purified Protein Derivative (PPD) = 5 mm of induration and/or chest X-ray (CXR) findings suggestive of latent TB; EXCEPT if prophylactic treatment, as recommended by local guidelines, is initiated prior to administration of study drug or there is documentation that the subject has received prophylactic treatment for TB previously, see Appendix D of the study protocol (US Center for Disease Control [CDC] Treatment Recommendations for Positive PPD Tuberculosis Information - Treatment of Latent TB Infection); ? Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Screening; ? Infection requiring treatment with antibiotics in the two weeks prior to Screening; ? Subject has received vaccination with Bacille Calmette-Guerin (BCG) within 12 months prior to Screening; ? Subject has received vaccination with a live viral agent one month prior to Screening or will requi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the short-term and long-term clinical efficacy, safety and tolerability of ABT-874 compared to MTX in the treatment of moderate to severe chronic plaque psoriasis over a 24 and 52-week period.;Secondary Objective: ;Primary end point(s): 1. The proportion of subjects who achieve a PASI 75 response defined as at least 75% reduction in PASI score relative to Baseline at Week 24, 2. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24, 3. The proportion of subjects who achieve a PASI 75 response defined as at least 75% reduction in PASI score relative to Baseline at Week 52, 4. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52. | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed