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Trial record 4 of 8 for:    acthar | Uveitis

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

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ClinicalTrials.gov Identifier: NCT03656692
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
The primary objective of this study is to explore the efficacy of Acthar in participants with severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU). in reducing aqueous and vitreous indicators of inflammation.

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis Drug: Acthar Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Pilot Study to Explore the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis NIPPU
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : February 27, 2020
Estimated Study Completion Date : February 27, 2020


Arm Intervention/treatment
Acthar
Acthar, 1 mL (80 U) SC doses 2x/week for 36 weeks, followed by a taper to 1 mL (80 U) SC doses once per week for two weeks and then 0.5 mL (40 U) SC once a week for an additional 2 weeks
Drug: Acthar
See Arm Description




Primary Outcome Measures :
  1. Percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in vitreous haze at Week 36 [ Time Frame: Week 36 ]
    Nussemblatt grading scale was used to measure vitreous haze, using the photographic scale: grades 0-4+ (lower values were considered better outcome). Here, percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in vitreous haze at Week 36, was calculated.

  2. Percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in aqueous flare at Week 36 [ Time Frame: Week 36 ]
    Laser flare meter 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare) was used to calculate the amount of aqueous flare (protein escaping from dilated vessels). Here, percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in aqueous flare at Week 36, was calculated.

  3. Percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in aqueous cells at Week 36 reduction from baseline (or achievement of Grade 0) in aqueous cells [ Time Frame: Week 36 ]
    Aqueous cells were measured on a 5-unit scale from 0 (none) to 4 (> 30 cells), lower values were considered better outcome. Here, percentage of participants with a 2 or more step reduction from baseline (or achievement of Grade 0) in aqueous cells at Week 36, was calculated.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Baseline to 36 weeks ]
    Comprehensive assessment of clinical and ocular safety including adverse events will be collected

  2. Change in intraocular pressure (IOP) [ Time Frame: Change from baseline in IOP at 36 weeks ]
    The mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint using Goldmann Applanation Tonometry (GAT).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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-α] 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, 2018) 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.
  12. Any primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
  13. Any current congestive heart failure (defined as New York Heart Association
  14. Participant has a history of chronic active hepatitis including active or chronic hepatitis B, or acute or chronic hepatitis C.
  15. 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.
  16. 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.
  17. 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.
  18. Participant has any of the following laboratory abnormalities at the Screening Visit: Hemoglobin ≤ 8.0 g/dL. Platelets ≤ 50,000 cells/μL. Absolute neutrophil count (ANC) ≤ 1000 cells/μL. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin 2 times upper limit of normal (ULN).
  19. 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).
  20. 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


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): NCT03656692


Contacts
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Contact: Study Manager 908-238-5498 clinicaltrails@mnk.com
Contact: Study Director 908-238-5580 clinicaltrails@mnk.com

Locations
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United States, Arizona
Retinal Research Institute, LLC Recruiting
Phoenix, Arizona, United States, 85014
Retina Center PC Recruiting
Tucson, Arizona, United States, 85704
United States, Florida
Blue Ocean Clinical Research Recruiting
Clearwater, Florida, United States, 33761
United States, Illinois
University Retina and Macula Associates PC Recruiting
Lemont, Illinois, United States, 60439
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Massachusetts Eye Research and Surgery Institution (MERSI) Recruiting
Waltham, Massachusetts, United States, 02451
United States, New Jersey
Metropolitan Eye Research and Surgery Institute Recruiting
Palisades Park, New Jersey, United States, 07650
Metropolitan Eye Research and Surgery Institute Recruiting
Teaneck, New Jersey, United States, 07666
United States, North Dakota
Bergstrom Eye Research, LLC Recruiting
Fargo, North Dakota, United States, 58103
United States, Texas
Austin Retina Associates Recruiting
Austin, Texas, United States, 78705
Valley Retina Institute, PA Recruiting
McAllen, Texas, United States, 78503
Foresight Studies, LLC Recruiting
San Antonio, Texas, United States, 78240
United States, Virginia
Virginia Eye Consultants Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: MNK Study Director Mallinckodt Pharmaceuticals

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03656692     History of Changes
Other Study ID Numbers: MNK61074105
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Adrenocorticotropic Hormone
Panuveitis
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs