Phase 3
N=425
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01646073 ↗Enrolled (actual)
425
Serious AEs
2.6%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 — 11.5; 77.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological); placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 |
11.5; 77.8 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A] |
0; 9.8; 2.3; 45.3 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] |
51.8; 87.4; 80.0; 87.1; 90.6; 87.7 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A] |
-20.44; -82.20 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B] |
-91.39; -91.07 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] |
1.1; 31.7; 0; 2.7; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] |
71.8; 93.4; 28.2; 70.0; 8.2; 20.4 | — |
| SECONDARY Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] |
0; 0; 0; 0.6; 0; 12.1 | — |
| SECONDARY Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B] |
14.1; 39.3; 29.4; 42.9; 41.2; 45.6 | — |
| SECONDARY Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] |
0; 0; 0; 20.1; 4.6; 57.4 | — |
| SECONDARY Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B] |
61.2; 85.6; 84.7; 84.4; 89.4; 83.8 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A] |
0; 0.9; 1.1; 3.3; 0; 13.0 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B] |
12.9; 15.0; 23.5; 19.5 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A] |
1.1; 2.4; 3.4; 9.2; 10.3; 28.4 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B] |
27.1; 30.0; 44.7; 37.8 | — |
| SECONDARY Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A] |
1.13; 4.22; 1.91; 7.02 | — |
| SECONDARY Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B] |
4.20; 4.73; 5.74; 7.76 | — |
Summary
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of psoriasis for at least 6 months.
- Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
- Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
- Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
- Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
Exclusion Criteria
- Diagnosis of other active skin diseases or skin infections.
- Participant has known hypersensitivity to adalimumab or it excipients.
- Participant has chronic recurring infections or active tuberculosis.
- Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- Participant is known to have immune deficiency or is immunocompromised.
Data sourced from ClinicalTrials.gov (NCT01646073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.