At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 318 enrolled
Drug / intervention
BI 695501 +1 moredrug
Likely dose
Adalimumab (BI 695501 or Humira) - typical psoriasis dosingAI-extracted
Key inclusion· 6
- ✓Age 18 to 80 years
- ✓Moderate to severe chronic plaque psoriasis diagnosed ≥6 months prior, stable for ≥2 months
- ✓BSA ≥10%
- ✓PASI score ≥12
Key exclusion· 9
- ✕Prior treatment with >1 biologic agent or any prior adalimumab/adalimumab biosimilar
- ✕Any biologic exposure within 6 months of screening
- ✕Active or history of malignancy within 5 years (except treated basal cell carcinoma or cervical CIS)
- ✕Known or suspected active tuberculosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial
In Brief
A Phase 3 clinical trial evaluating BI 695501 and Humira for Psoriasis. Completed, enrolled 318 participants across 54 sites in 8 countries.
Detailed Summary
To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCzechia, Estonia, Germany, Poland, Russia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartAug 2016
Primary CompletionJan 2018
TodayJul 2026
First PostedAug 1, 2016
Enrollment StartAug 17, 2016
Primary CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.9 years ago
Interventions
BI 695501drug
Humiradrug