Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Study Evaluating the Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02267642
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
AbGenomics B.V Taiwan Branch

Brief Summary:
To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: AbGn-168H Phase 2

Detailed Description:
This is an open-label, multi-center, multi-dose phase II proof of principle trial to study the efficacy and safety of AbGn-168H in patients with moderate to severe active psoriatic arthritis. A minimum of 15 patients and a maximum of 20 will be recruited in 1 dosing group. For safety evaluation, the parameters to be assessed include physical examination, vital signs (blood pressure, heart rate, respiratory rate and body temperature), 12-lead ECG, safety laboratory tests, adverse events and tolerability. For efficacy evaluation, patients will be evaluated for proportion of subject reaching American College of Rheumatology 20 (ACR 20) in week 12 and proportion of subjects reaching ACR 20, ACR 50 and ACR 70 at different time points; Disease Activity Score 28 (DAS28) at different time points, as well as Target Lesion Psoriasis Severity Score (TLPSS) and static Physician Global Assessment (sPGA) for subjects with active skin lesions at different time point.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis: a 24-week, Open-label, Multi-center, Phase II Proof of Principle Trial.
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AbGn-168H
Seven (7) intravenous doses of AbGn-168H on D1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day D29 (Week 4), D43 (Week 6), Day 57 (Week 8) and Day 71 (Week 10)
Biological: AbGn-168H
monoclonal antibody




Primary Outcome Measures :
  1. Proportion of subject reaching American College of Rheumatology score 20 (ACR20) [ Time Frame: at 12-week after the first treatment ]

Secondary Outcome Measures :
  1. Proportion of subjects reaching American College of Rheumatology score 20, 50 and 70 (ACR 20, ACR 50 and ACR70) [ Time Frame: up to 24 weeks after the first treatment ]
  2. Disease Activity Score 28 (DAR28) [ Time Frame: up 24 weeks after the first treatment ]
  3. Target Lesion Psoriasis Severity Score (TLPSS) for subjects with active skin lesions [ Time Frame: up 24 weeks after the first treatment ]
  4. static Physician's Global Assessment (sPGA) for subjects with active skin lesions [ Time Frame: up to 24 weeks after the first treatment ]
  5. Number of subjects with Adverse Event [ Time Frame: up to 24 weeks after the first treatment ]
  6. Immunogenicity [ Time Frame: up to 24 weeks after the first treatment ]
  7. Number of subject with abnormal clinical laboratory parameters [ Time Frame: up to 24 weeks after the first treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Patient must give informed consent and sign an approved consent form prior to any study procedures
  2. Age 18 to 75 (inclusive), males or females
  3. Body weight < 140 kg
  4. Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria.
  5. Patients must have moderate to severe active PsA at screening and baseline, defined as having greater than or equal to 3 tender (out of 68) and 3 swollen (out of 66) joints.
  6. Patients must have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesions score (scalp and groin lesions cannot be used), or documented psoriasis history.
  7. Patients must have history of inadequate response or intolerance to NSAID or DMARD defined by the investigator.
  8. If the patient is taking background corticosteroids, dose must be ≤ 10 mg/day prednisone (or equivalent) and must have been at a stable dose for at least 4 weeks prior to screening.
  9. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of psoriasis arthritis is permitted if the dose has been stable for at least 2 weeks prior to screening.
  10. If the patient is taking methotrexate (MTX), the patient must have received methotrexate 7.5-25 mg/wk (p.o. or parenteral) for at least 12 weeks and at a stable dose for 4 weeks prior to screening. If the patient is not taking MTX, they must have been off the drug for at least 8 weeks prior to receiving the first dose (baseline).
  11. Folic acid or folinic acid is required at least 1 mg per day or 5 mg per week for all patients taking MTX.
  12. Whether or not the patient is taking methotrexate, all DMARDs (other than MTX) should be withdrawn at least 4 weeks prior to baseline (Visit 2) of first drug administration (4 weeks for etanercept, 8 weeks for infliximab, adalimumab, golimumab, certolizumab pegol and leflunomide, and 12 weeks for ustekinumab, c.f. Section 4.2.2). Subjects taking appremilast should discontinue the medication 2 weeks prior to receiving the first dose (baseline).
  13. Females of childbearing potential must have a negative pregnancy test result prior to enrolment. Male and female of childbearing potential must agree to use a highly effective method of birth control during the study.

A female is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal ligation and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.

A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).

Exclusion criteria

  1. History of malignancy in the past 5 years or suspicion of active malignant disease.
  2. Evidence of current or previous clinically significant disease, medical condition other than psoriatic arthritis, 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.
  3. Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response.
  4. HIV infection or a known HIV-related Malignancy.
  5. Chronic or acute hepatitis B and C, or carrier status.
  6. History of recurrent significant infection; known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
  7. Tuberculosis or a positive Quantiferon test for tuberculosis.
  8. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients.
  9. Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study.
  10. Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3). Patients with Orencia or Toclizumab treatment within 8 weeks, IVIG, Natalizumab or Prosorba Column treatment within 6 months, and anti-CD19 or anti-CD20 treatment within 1 year should be excluded.
  11. Immunization with a vaccine within 4 weeks prior to baseline (Visit 2) of the first drug administration (e.g.; MMR, Varivax).
  12. Current alcohol abuse.
  13. 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 (Section 4.2.2 of the protocol) can be enrolled.
  14. Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:

    • Haemoglobin < 9 g/dL, hematocrit, white blood cell count, absolute lymphocyte or platelet count < LLN (below the lower limit of the reference normal range), or absolute neutrophil < 1500/µL
    • ALT, AST and/or total bilirubin > 2 x ULN
    • Serum creatinine > 1.5 x ULN
  15. Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267642


Locations
Layout table for location information
United States, California
UC San Diego
La Jolla, California, United States, 92037
Stanford University
Palo Alto, California, United States, 94304
United States, Florida
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Justus J. Fiechtner, MD, PC
Lansing, Michigan, United States, 48910
United States, Texas
Metroplex Clinical Research Center, LLC
Dallas, Texas, United States, 75231
United States, Washington
Seattle Rheumatology Associates/Swedish Clinical Research
Seattle, Washington, United States, 98122
Sponsors and Collaborators
AbGenomics B.V Taiwan Branch
Investigators
Layout table for investigator information
Study Director: Shih-Yao Lin, MD, PhD AbGenomics B.V Taiwan Branch
Principal Investigator: Mark Genovese, MD Stanford University

Layout table for additonal information
Responsible Party: AbGenomics B.V Taiwan Branch
ClinicalTrials.gov Identifier: NCT02267642     History of Changes
Other Study ID Numbers: 2014.009.01
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases