Trial Search Results
A Phase II Study Evaluating the Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis
To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis.
Stanford is currently not accepting patients for this trial.
AbGenomics B.V Taiwan Branch
- Biological: AbGn-168H
1. Patient must give informed consent and sign an approved consent form prior to any
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
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be withdrawn at least 4 weeks prior to baseline (Visit 2) of first drug administration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
A highly effective method of birth control is defined as one which results in a low failure
rate (less than 1% per year).
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
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
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study