Psoriasis
Conditions
Brief summary
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Interventions
DRUGadalimumab
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of moderate to severe chronic plaque psoriasis * Active psoriasis, despite topical therapies
Exclusion criteria
* Other active skin diseases or skin infections * Prior exposure to any anti-TNF therapy * Subject has other active skin diseases * Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) * Poorly controlled medical conditions * History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease * History of cancer or lymphoproliferative disease * History of active TB or listeriosis, or persistent chronic or active infections * Known to have immune deficiency or is immunocompromised * Clinically significant abnormal laboratory test results * Erythrodermic psoriasis or generalized pustular psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index | Week 12-Week 24 |
| Adverse Events | Throughout Study Participation |
Secondary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index | Week 12, Week 24 through 360 days after last dose |
| Physician's Global Assessment | Week 12, Week 24 through 360 days after last dose |
Outcome results
None listed