Last updated on May 2019

Efficacy and Safety of H.P. Acthar Gel in Subjects With Severe Noninfectious Intermediate Uveitis Posterior Uveitis or Panuveitis NIPPU

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic cyclitis | Panuveitis | Posterior uveitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

  1. Participants must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date on the ICF.
  2. Participants must be 18 years of age at Screening Visit and can be male or female.
  3. Participants must have been diagnosed with current severe NIPPU and have active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone 10 mg/day to 60 mg/day (or oral corticosteroid equivalent): Active, inflammatory, horioretinal and/or inflammatory retinal vascular lesion. 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria). 2+ vitreous haze (Nussenblatt et al, 1985).
  4. Participants entering the study on 1 concomitant immunosuppressive therapy must not have had the dose increased in the 2 weeks prior to the Baseline Visit and must be within the following allowable doses at the Baseline Visit:
    • Methotrexate 15 mg per week.
    • Cyclosporin 4 mg/kg per day.
    • Mycophenolate mofetil 2 g per day or an equivalent drug (eg, mycophenolic acid) at an equivalent dose that has been approved by the medical monitor (MM).
    • Azathioprine 175 mg per day.
    • Tacrolimus (oral formulation) 8 mg per day.
    • Adalimumab 40 mg SC every other week. 5. Participants must be willing to taper their current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study. 6. Female Participants must be of nonchildbearing potential (history of hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or if of childbearing potential must be nonpregnant, nonlactating and agree to use effective contraception when with a male partner throughout study participation (through the Follow-up Visit). Acceptable forms of contraception include hormonal measures (oral contraceptive pills, contraceptive patch, contraceptive ring, injections), intrauterine devices, double barrier method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), and abstinence.

Exclusion Criteria:

  1. Participant is from a vulnerable population, as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB/IEC.
  2. Participant has a history of sensitivity to ACTH preparations or sensitivity to porcine protein products.
  3. Participant has had recent (within the previous 6 months) diabetic retinopathy, age-related macular degeneration, intraocular surgery or ocular trauma, cataracts, or posterior capsule opacification.
  4. Participant is under treatment with any corticosteroids, immunosuppressants, immunomodulators, or biologic agents for a concomitant condition (eg, rheumatoid arthritis under treatment with a tumor necrosis factor- alpha [TNF-] drug). Participants are specifically excluded for any of the following:
  5. Participant has received (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device and/or Participant has had removal within 90 days prior to the Baseline Visit or has had complications related to the removal of the device.
  6. Participant has received intraocular or periocular corticosteroids within 30 days prior to Baseline Visit.
  7. Participant has proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy.
  8. Participant has neovascular/wet age-related macular degeneration.
  9. Participant has an abnormality of a vitreoretinal interface (ie, vitreomacular traction, epiretinal membranes, etc) with the potential for macular structural damage independent of the inflammatory process.
  10. Participant has a severe vitreous haze that precludes visualization of the fundus at the Baseline Visit.
  11. Participant has any known contraindication(s) to Acthar (Mallinckrodt Package Insert,
  12. including, but not limited to: Any known history of scleroderma, osteoporosis, or ocular herpes simplex. For the purposes of this study, osteoporosis is defined as evidence of current vertebral or long bone fracture, or lumbar T-score > 2.0 SD below the mean of the reference population.
  13. Any primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
  14. Any current congestive heart failure (defined as New York Heart Association
  15. Participant has a history of chronic active hepatitis including active or chronic hepatitis B, or acute or chronic hepatitis C.
  16. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.
  17. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.
  18. Participant has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Screening Visit; with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
  19. Participant has any of the following laboratory abnormalities at the Screening Visit: Hemoglobin 8.0 g/dL. Platelets 50,000 cells/L. Absolute neutrophil count (ANC) 1000 cells/L. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin 2 times upper limit of normal (ULN).
  20. Glycosylated hemoglobin (HbA1c) 6.5. Positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), or positive Hepatitis C virus antibody (HCV). (If HCV is positive at screening, HCV polymerase chain reaction [PCR] will be automatically analyzed. Participants with a positive HCV must have HCV PCR < 25 IU/mL at the Screening Visit to be eligible).
  21. Participant has any other clinically significant disease, disorder or laboratory abnormality (including those listed on the Prescribing Information Section 5: Warnings and Precautions [Mallinckrodt Package Insert, 2018]) which, in the opinion of the investigator (by its nature or by being inadequately controlled), might put the patient at risk due to participation in the study, or may influence the results of the study or the Participant's ability to complete the study.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.