Adults 18 to 80, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Plasma Concentration Time Curve Over the Dosing Interval of Week 30 to 32 (AUCτ, 30-32) for Adalimumab in PlasmaPrimary· Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.
Area Under the Plasma Concentration Time Curve Over the 2 weeks dosing Interval between Week 30 to 32 (AUCτ, 30-32) for Adalimumab in plasma was reported.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
2040
± 1420
Continuous Humira (Post-Randomization Period)
1980
± 1600
Maximum Observed Concentration During the Dosing Interval Week 30-32 (Cmax, 30-32) for Adalimumab in PlasmaPrimary· Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.
Maximum observed concentration during the 2 weeks dosing interval between Week 30 to 32 (Cmax, 30-32) for Adalimumab in plasma was reported.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
7.13
± 4.63
Continuous Humira (Post-Randomization Period)
7.14
± 5.37
Minimum Observed Concentration During the Dosing Interval of Week 30 to 32 (Cmin, 30-32) for Adalimumab in PlasmaSecondary· Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.
Minimum Observed Concentration During the 2 weeks Dosing Interval between Week 30 to 32 (Cmin, 30-32) for Adalimumab in plasma was reported.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
5.04
± 3.89
Continuous Humira (Post-Randomization Period)
4.66
± 4.19
Time to Maximum Observed Concentration During the Dosing Interval of Week 30 to 32 (Tmax, 30-32) for Adalimumab in PlasmaSecondary· Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.
Time to Maximum Observed Concentration During the 2 weeks Dosing Interval between Week 30 to 32 (tmax, 30-32) for Adalimumab in plasma was reported.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
72.7
66.0 – 336
Continuous Humira (Post-Randomization Period)
72.3
46.8 – 240
Percentage of Patients With a 75% Reduction in Psoriasis Area and Severity Index (PASI75) Response at Week 32Secondary· At week 32
The PASI is an established measure of clinical efficacy for psoriasis medications. The PASI is a tool which provides a numeric scoring for patients' overall psoriasis disease state, with scores ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, trunk, upper extremities and lower extremities). Higher PASI scores indicate more severe psoriasis. PASI is generally summarized as a dichotomous outcome based on achieving over an X percent(%) reduction from baselin
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
84.75
Continuous Humira (Post-Randomization Period)
78.99
Percentage of Patients With a Static Physician's Global Assessment (sPGA) Score ≤ 1 (Clear or Almost Clear) at Week 32Secondary· At week 32
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static", which refers to the patient's disease state at the time of the assessments, without comparison to any of the patient's previous disease states (dynamic), whether at baseline or at a previous visit. A lower score indicates less body coverage and a higher score indicates more severe disease (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe). Results are reported for percentage of pat
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
70.34
Continuous Humira (Post-Randomization Period)
64.71
Number of Patients With Anti-drug Antibody (ADA) to Adalimumab at Week 32Secondary· Immunogenicity samples were collected pre-dose at Week 32.
Number of patients with a confirmed positive anti-drug antibody (ADA) response to Adalimumab (BI 695501 or Humira) at Week 32. A participant was considered "ADA positive" if the blank normalized signal in the ADA screening assay was equal to or above the study specific ADA screening cut point factor of 1.06 and the signal inhibition by drug in the ADA confirmatory assay was equal to or above the study specific ADA confirmatory cut points (11.4% for signal inhibition with Humira and 12.0% for signal inhibition with BI 695501).
Negative
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
11
Continuous Humira (Post-Randomization Period)
6
Positive
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
101
Continuous Humira (Post-Randomization Period)
104
Total reportable
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
112
Continuous Humira (Post-Randomization Period)
110
Not reportable
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
0
Continuous Humira (Post-Randomization Period)
2
Number of Patients With Neutralizing Antibody (nAb) to Adalimumab at Week 32Secondary· Immunogenicity samples were collected pre-dose at Week 32.
Number of patients with a positive neutralizing anti-drug antibody (nAb) response to Adalimumab (BI 695501 or Humira) at Week 32. A participant was considered "nAb positive" if the blank normalized signal in the nAb screening assay was equal to or below the study specific nAb screening cut point factor of 0.836.
Negative
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
66
Continuous Humira (Post-Randomization Period)
64
Positive
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
46
Continuous Humira (Post-Randomization Period)
46
Total reportable
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
112
Continuous Humira (Post-Randomization Period)
110
Not reportable
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
0
Continuous Humira (Post-Randomization Period)
2
Anti-drug Antibody (ADA) Titer of Patients With ADA at Week 32Secondary· Immunogenicity samples were collected pre-dose at Week 32.
Anti-drug antibody (ADA) titer of patients with a confirmed positive ADA response to Adalimumab (BI 695501 or Humira) at Week 32.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
64.0
32.00 – 256.00
Continuous Humira (Post-Randomization Period)
128
16.00 – 256.00
Neutralizing Anti-drug Antibody (nAb) Titer of Patients With nAb at Week 32Secondary· Immunogenicity samples were collected pre-dose at Week 32.
Neutralizing anti-drug antibody (nAb) titer of patients with a positive nAb response to Adalimumab (BI 695501 or Humira) at Week 32.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
2.0
1.00 – 4.00
Continuous Humira (Post-Randomization Period)
2.0
1.00 – 2.00
Percentage of Patients With Drug-related Adverse Events (AEs) During the Post-Randomization PeriodSecondary· From first dose of trial post-randomization medication until 10 weeks after last dose of trial post-randomization medication, up to 44 weeks
Analysis of AEs focused on treatment-emergent adverse events (TEAEs) and is presented here for the post-randomization period (Week 14 to 58). For the post-randomization period analysis, TEAEs were defined as AEs that started or worsened on or after the first dose of trial post-randomization medication and prior to the last dose of trial post-randomization medication + 10 weeks.
Group
Value
95% CI
Switching Arm (Post-Randomization Period)
11.9
Continuous Humira (Post-Randomization Period)
18.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From first post-randomized trial medication until 10 weeks after last dose, up to 44 weeks (Post-Randomization Period). From first dose of Humira and prior to the first dose of post-randomization medication+10 weeks, up to 24 weeks (Run-In Period)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Humira Containing All RTS Subjects (Run-In Period)
The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis.
The secondary objectives of this trial are to descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03759288 — An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
· Phase 2, PHASE3
· terminated
NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
· Phase 3
· completed
NCT02660580 — MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
· Phase 3
· completed
NCT02405780 — A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
· Phase 3
· completed
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria
· NA
· recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
· recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
· recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial
· Phase 2
· recruiting
NCT07250997 — PALLAS Laser for Skin Diseases
· NA
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 14 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03210259.