Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
- Registration Number
- NCT02850965
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Humira Humira - BI 695501 BI 695501 -
- Primary Outcome Measures
Name Time Method The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 Week 16 The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = \<10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5 = 70 to \<90%, and 6 = 90 to 100% involvement.
PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.
Percentage = least squares means per treatment groups back transformed using inverse logit function.
- Secondary Outcome Measures
Name Time Method The Mean Percentage Improvement in PASI at Week 16 Week 16 The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 =\<10%, 2 =10 to \<30%, 3 =30 to \<50%, 4 =50 to \<70%, 5 =70 to \<90%, and 6 =90 to 100% involvement.
PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.
Results based on PASI mean percentage improvement from Baseline after 16 weeks of treatment = overall mean + treatment group + Baseline PASI + prior exposure to a biological agent + random error.The Percentage of Patients With a PASI 75 Response at Week 24 Week 24 The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = \<10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5 = 70 to \<90%, and 6 = 90 to 100% involvement.
PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.
Percentage = least squares means per treatment groups back transformed using inverse logit function.The Percentage of Patients With a Static Physician's Global Assessment (sPGA) ≤1 (Clear or Almost Clear) at Week 16 Week 16 The Static Physician's Global Assessment (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 was considered "static", which referred to the patient's disease state at the time of the assessment, without comparison to any of the patient's previous disease states (dynamic), whether at Baseline or at a previous visit. A lower score indicated less body coverage, with 0 being clear, 1 being almost clear, and 4 being.
Percentage = least squares means per treatment groups back transformed using inverse logit function.The Percentage of Patients With Drug-related Adverse Events (AEs) From first drug administration until 10 weeks after last drug administration, up to 34 weeks. The secondary safety endpoint was defined as the percentage of patients with drug-related adverse events (AEs).
The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 Week 16 The DLQI is a subject-administered, 10-question, that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has a 1-week recall period. Every item score ranges from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes/no" question where "yes" is scored as 3.
The DLQI total score was calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on the subject's life.
The higher the score, the more the quality of life is impaired. If the answer to 1 question in a domain was missing, that domain was treated as missing. If 2 or more questions were left unanswered (missing), DLQI total score was treated as missing. Percentage = least squares means per treatment groups back transformed using inverse logit function.
Trial Locations
- Locations (54)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Alliance Dermatology and MOHS Center PC
🇺🇸Phoenix, Arizona, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research, P.C.
🇺🇸Duncansville, Pennsylvania, United States
Medical Research South
🇺🇸Charleston, South Carolina, United States
Dorothea
🇨🇿Chomutov, Czechia
University Hospital Ostrava
🇨🇿Ostrava, Czechia
MU Dr. Helena Korandova s.r.o., Olomouc-Povel
🇨🇿Olomouc-Povel, Czechia
HOMEA spol. s.r.o., Pardubice
🇨🇿Pardubice, Czechia
Univ. Hospital Kralovske Vinohrady
🇨🇿Praha, Czechia
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
MU Dr. Jaroslav Dragon, Ústí nad Labem
🇨🇿Ústí nad Labem, Czechia
Rothhaar Studien GmbH
🇩🇪Berlin, Germany
Gemeinschaftspraxis Dr. Bräu Dr. Gross, Gießen
🇩🇪Gießen, Germany
Rosenparkklinik GmbH, Darmstadt
🇩🇪Darmstadt, Germany
NZOZ Specderm, Bialystok
🇵🇱Bialystok, Poland
TFS Trial Form Support GmbH
🇩🇪Hamburg, Germany
NSZOZ Unica CR, Dabrowka
🇵🇱Dabrowka, Poland
Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
🇵🇱Gdansk, Poland
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
🇵🇱Gdynia, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
🇵🇱Katowice, Poland
SOLUMED Centrum Medyczne, Poznan
🇵🇱Poznan, Poland
State Medical University, Kazan
🇷🇺Kazan, Russian Federation
Laser Clin. S.C. Dr T. Kochanowski Dr A. Krolicki, Szczecin
🇵🇱Szczecin, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa
🇵🇱Warszawa, Poland
Dermatovenereological Dispensary #10, St. Petersburg
🇷🇺Saint-Petersburg, Russian Federation
ArsVitae NorthWest LLC
🇷🇺Saint-Petersburg, Russian Federation
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
🇷🇺Saint-Petersburg, Russian Federation
Smolensk State Medical University, Smolensk
🇷🇺Smolensk, Russian Federation
EKO-Bezopasnost, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
Institution of Healthcare "Nikolaevskaya Hospital"
🇷🇺St. Petersburg, Russian Federation
Faculty hospital with clinics F.D. Roosevelta
🇸🇰Banska Bystrica, Slovakia
CH of State Border Service of Ukraine, Lviv
🇺🇦Lviv, Ukraine
CI Odesa Regional Dermatovenerologic Dispensary, Odesa
🇺🇦Odesa, Ukraine
CI RC Dermatovenerologic Dispensary, Ivano-Frankivsk
🇺🇦Saint Ivano-Frankivsk, Ukraine
SI Ternopil Regional Dermatovenerologic Dispensary, Ternopil
🇺🇦Ternopil, Ukraine
MCIC MC LLC Health Clinic, Vinnytsia
🇺🇦Vinnytsia, Ukraine
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Southern California Dermatology Inc.
🇺🇸Santa Ana, California, United States
Advanced Clinical Research
🇺🇸Boise, Idaho, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Dermatovenerologicke oddelenie sanatorneho typu, Svidnik
🇸🇰Svidnik, Slovakia
Territorial Medical Association Dermatovenerology, Kyiv
🇺🇦Kyiv, Ukraine
Center for Clinical and Basic Research, Tallinn
🇪🇪Tallinn, Estonia
ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok
🇵🇱Bialystok, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw
🇵🇱Wroclaw, Poland
Hospital of South-Estonia Ltd, Võru Maakond
🇪🇪Võru Maakond, Estonia