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

Not Recruiting

Trial ID: NCT02267642


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

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.

Stanford Investigator(s)

Mark Genovese
Mark Genovese

James W. Raitt M.D. Professor, Emeritus


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

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   be withdrawn at least 4 weeks prior to baseline (Visit 2) of first drug administration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).

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


biological: AbGn-168H

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305