Recruitment

Recruitment Status
Completed
Estimated Enrollment
48

Inclusion Criterias

Patient must give informed consent and sign an approved consent form prior to any study procedures
Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Age 18 to 75 (inclusive), males or females
...
Patient must give informed consent and sign an approved consent form prior to any study procedures
Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Age 18 to 75 (inclusive), males or females
Body weight < 140 kg
Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2, with at least 1 lesion for target lesion assessment.
Psoriasis disease duration of at least 6 months prior to screening
Patients must be candidates for systemic psoriasis treatment or phototherapy

Exclusion Criterias

ALT, AST and/or total bilirubin > 2.5xULN
Use of biologic agents or investigational drug within 12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
...
ALT, AST and/or total bilirubin > 2.5xULN
Use of biologic agents or investigational drug within 12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
Any blood donation or significant blood loss within 4 weeks prior to Visit 2
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)
Tuberculosis, or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
Serum creatinine > 1.5x ULN
History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri.
Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
History of alcohol abuse
Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
History of drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons (section 4.2.2 of the protocol) can be enrolled.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
HIV infection or a known HIV-related Malignancy.

Summary

Conditions
Moderate to Severe Chronic Plaque Psoriasis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Inclusion Criterias

Patient must give informed consent and sign an approved consent form prior to any study procedures
Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Age 18 to 75 (inclusive), males or females
...
Patient must give informed consent and sign an approved consent form prior to any study procedures
Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Age 18 to 75 (inclusive), males or females
Body weight < 140 kg
Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2, with at least 1 lesion for target lesion assessment.
Psoriasis disease duration of at least 6 months prior to screening
Patients must be candidates for systemic psoriasis treatment or phototherapy

Exclusion Criterias

ALT, AST and/or total bilirubin > 2.5xULN
Use of biologic agents or investigational drug within 12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
...
ALT, AST and/or total bilirubin > 2.5xULN
Use of biologic agents or investigational drug within 12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
Any blood donation or significant blood loss within 4 weeks prior to Visit 2
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)
Tuberculosis, or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
Serum creatinine > 1.5x ULN
History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri.
Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
History of alcohol abuse
Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
History of drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons (section 4.2.2 of the protocol) can be enrolled.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
HIV infection or a known HIV-related Malignancy.

Locations

Richmond, Virginia, 23233
Orange, Florida, 32127
Huston, Texas, 77056
New York, New York, 10016
Greer, South Carolina, 29650
...
Richmond, Virginia, 23233
Orange, Florida, 32127
Huston, Texas, 77056
New York, New York, 10016
Greer, South Carolina, 29650
Tampa, Florida, 33609
Indianaopoli, Indiana, 46256
Berlin, New Jersey, 08009
Little Rock, Arkansas, 72205
Indianapolis, Indiana, 46202
Boynton Beach, Florida, 33472
Oklahoma City, Oklahoma, 73112
Rogers, Arkansas, 72758
New York, New York, 10029
Ocala, Florida, 34471

Tracking Information

NCT #
NCT01855880
Collaborators
Not Provided
Investigators
  • Study Director: Shih-Yao Lin, MD, PhD AbGenomics B.V Taiwan Branch Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai
  • Study Director: Shih-Yao Lin, MD, PhD AbGenomics B.V Taiwan Branch Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai