Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01769937
• Date of registration: 15/01/2013
• Prospective Registration: No
• Primary sponsor: Fiechtner, Justus J., M.D., P.C.
• Public title: Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus ACTH
• Scientific title: A Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: October 2012
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01769937
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Justus J Fiechtner, MD, MPH
• Affiliation: Justus J. Fiechtner, MD, PC

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects must meet all of the following criteria:

1. In the opinion of the investigator, must have adequate reading and writing abilities
(in their native language) such that the subject can comprehend and complete the
informed consent, and all protocol-related assessments

2. Age 18-75 years at the time of screening

3. Written informed consent and any locally required authorization (eg. HIPAA) obtained
from the subject prior to performing any protocol-related procedures, including
screening evaluations

4. Fulfills at least 4 of the 11 American College of Rheumatology (ACR) classification
criteria for SLE, including a history of ANA positivity

5. Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing
treatment or observation for > 8 weeks prior to screening.

6. Currently receiving at least one of the following:

1. A stable dose of oral prednisone (or equivalent) < 20mg/day from at least 4weeks
(28 days) prior to signing of the informed consent

2. Any of the following medications administered at a stable dose for a minimum of
8 weeks (56 days) prior to signing of the informed consent form

i) Azathioprine ii) Antimalarials (eg. Chloroquine, hydroxychloroquine, quinacrine)
iii) Mycophenolate mofetil/mycophenolic acid iv) Weekly administration of oral or SQ
Methotrexate

7. At screening and randomization (Day 0) must meet SLE Flare criteria

8. Females of childbearing potential must use an effective method of birth control and
avoid pregnancy from screening through 90 days after the final dose of Acthar unless
surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or
complete hysterectomy), has a sterile male partner, is 1 year postmenopausal, or
practices abstinence.

-

Exclusion Criteria:

Any of the following would exclude the subject from participation in the study:

1. Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or confound interpretation of subject
safety or study results

2. Concurrent enrollment in any other clinical study with an investigational product
with 4 weeks (28 days) prior to Day 0 or within 5 half-lives of the investigational
product used in that clinical study, whichever is longer

3. Employees of the clinical study site or any other individuals involved with the
conduct of the study or immediate family members of such individuals

4. Any new oral prednisone therapy (or equivalent) or any change in current oral
prednisone dose (or equivalent) anytime from 4 weeks (28 days) prior to signing of
the informed consent

5. A known history of allergy or reaction to any component of the investigational
product

6. Any live or attenuated vaccine within 4 weeks (28 days) prior to signing the informed
consent form (administration of killed vaccines is acceptable)

7. Diagnosis of scleroderma, osteoporosis, fungal infections, ocular herpes simplex,
surgery within the past 4 weeks (28 days) or planned surgery within the next 4 weeks
(28 days)

8. History of or presence of peptic ulcer, congestive heart failure, uncontrolled
hypertension, primary adrenocortical insufficiency or adrenocortical hyperfunction or
sensitivity to proteins of porcine origin

9. Known history of a primary immunodeficiency or an underlying condition such as human
immunodeficiency virus (HIV) infection or splenectomy that predisposes the subject to
infection

10. History of any type of malignancy <5 years before randomization into the study (apart
from basal cell carcinoma)

11. Receipt of more than one prescribed NSAID at an anti-inflammatory dose with 4 weeks
(28 days) prior to Day 0

-



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lupus Erythematosus Systemic Exacerbation

Intervention(s)

Drug: H.P. Acthar Gel

Primary Outcome(s)

SLEDAI-2K score [Time Frame: 14 days]

Secondary Outcome(s)

BILAG-2004 [Time Frame: 14 days]

Secondary ID(s)

11191966

Source(s) of Monetary Support

Please refer to primary and secondary sponsors