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This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbGn-168H Low Dose | Experimental | Subject to receive low dose of AbGn-168H intravenously |
|
| AbGn-168H High Dose | Experimental | Subject to receive high dose of AbGn-168H intravenously |
|
| Placebo | Placebo Comparator | Subject to receive placebo intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbGn-168H | Biological | AbGn-168H monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 75% reduction in the Psoriasis Area Severity Index (PASI 75) | The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo. | at week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abnormal Physical Examination finding | At different time point for 20 weeks after the first treatment | |
| Cmax | Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject |
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Inclusion Criteria:
Exclusion Criteria:
Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
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)
HIV infection or a known HIV-related Malignancy.
Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination or cannot receive TST can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
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.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Use of biologic agents or investigational drug within 8-12 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
Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
Current alcohol abuse
Current 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 can be enrolled.
Any blood donation or significant blood loss within 4 weeks prior to Visit 2
Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:
Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening
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| Name | Affiliation | Role |
|---|---|---|
| Shih-Yao Lin, MD, Ph.D | AbGenmics B.V. Taiwan Branch | Study Director |
| Mark Lebwohl, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Dermatology & MOHS Center, PC | Phoenix | Arizona | 85032 | United States | ||
| Northwest AR Clinical Trials Center, PLLC. |
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| Placebo | Biological | Placebo of AbGn-168H |
|
| 12 weeks after the first treatment |
| Number of participants with Vital Sign change | At different time point for 20 weeks after the first treatment |
| Number of participants with abnormal ECG finding | At different time point for 20 weeks after the first treatment |
| Number of participants with abnormal Clinical Laboratory parameters | blood chemistry, hematology and urinalysis | At different time point for 20 weeks after the first treatment |
| Number of participants with Adverse Event | At different time point for 20 weeks after the first treatment |
| T1/2 | At different time point for 12 weeks after the first treatment |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Progressive Medical Research | Tampa | Florida | 33609 | United States |
| DawesFretzin Clinical Research Group, LLC. | Indianaopolis | Indiana | 46256 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Manhattan Medical Research Practice PLLC | New York | New York | 10016 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| High Point Clinical Trials Cente | High Point | North Carolina | 27265 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29650 | United States |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Katy | Texas | 77494 | United States |
| University of Utah Dermatology School of Medicine Dermatology 4A330 | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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