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ASIS for Enbrel in Plaque Psoriasis

Information source: ASIS Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis.

Intervention: Gadolinium (Drug); Gadolinium (Drug); Gadolinium (Drug); Efficacy of Enbrel subcutaneously at Week 12 (Drug); Efficacy of Enbrel subcutaneously at Week 24 (Drug); Efficacy of Enbrel subcutaneously at Week 36 (Drug); Efficacy of Enbrel subdermally at Week 12 (Drug); Efficacy of Enbrel subdermally at Week 24 (Drug); Efficacy of Enbrel subdermally at Week 36 (Drug); PASI 75 n(%) subcutaneously at Week 12 (Drug); PASI 75 n(%) subcutaneously at Week 24 (Drug); PASI 75 n(%) subcutaneously at Week 36 (Drug); PASI 75 n(%) subdermally at Week 12 (Drug); PASI 75 n(%) subdermally at Week 24 (Drug); PASI 75 n(%) subdermally at Week 36 (Drug); Adverse Reactions of Enbrel subcutaneously (Drug); Adverse Reactions of Enbrel subdermally at Week 36 (Drug); Gadolinium (Drug); Gadolinium (Drug); Gadolinium (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: ASIS Corporation

Official(s) and/or principal investigator(s):
Li Nguyen, MD, Principal Investigator, Affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Thanh Phung,, MD, Principal Investigator, Affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

Overall contact:
Li Nguyen, MD, Phone: (714)-453-7857, Email: dr.li.nguyen@asis-inc.com

Summary

AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only automatic injection system for delivery of injectable products to the optimum spot, just outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial (between the deeper muscles). ASIS device creates that bloodless space, enhancing Enbrel's efficacy and preventing unnecessary distant spread and adverse reactions. This space remains bloodless as long as the skin is lifted up or filled with an injectable product. Although ASIS device was initially designed to best administer BOTOX for such muscular conditions as Upper limb Spasticity, Cervical Dystonia, Chronic Migraine, Strabismus, Blepharospasm, and Primary Axillary Hyperhidrosis, the technology will also benefit other injectable products, including: GAMMAGARD for Primary Immunodeficiency (PI) and Insulin for Diabetics, etc.

Clinical Details

Official title: ASIS for Enbrel in Plaque Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Relative Prolongation Ability Score for Gadolinium subdermally injected.

Secondary outcome: Efficacy of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis.

Detailed description: Over 6 months, Aim 1 will demonstrate that ASIS device consistently delivers an injectable product (e. g. Gadolinium) into that subdermal bloodless space. MRI is the most simple and logical imaging choice, preferred because with ultrasound, air is injected, which will dissipate too quickly out of bloodless space to allow measurements. Since there isn't a way to measure the level of Gadolinium within that subdermal bloodless space, at least the Prolongation of Gadolinium may be approximated by its greater or longer Persistent % on MRI. Also, since we can't assume that bloodless space for patients with a particular disease will behave the same way as normal patients or patients with different diseases, this approximation only works if the variables are minimized to the same particular skin affected by Plaque Psoriasis. Case in point, patients with Plaque Psoriasis tend to have thicker skin, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which may be very different from the other diseases and certainly from the skin of normal patients, while the Gadolinium subdermally Persistent % should remain the same. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Plaque Psoriasis. However, they are valuable indicators that will help us modify the Enbrel dosage and duration to inject into that "unknown" subdermal space for Aim 2, from the "known" typical Enbrel dosage and duration for Plaque Psoriasis patients. For example, if Aim 1 found the Relative Prolongation Ability Score for the Plaque Psoriasis skin to be (2. 00), then the typical subcutaneously Enbrel 50mg every 3 days, should be 25mg every 6 days subdermally. Over 12 months, Aim 2 will again demonstrate the advantages of ASIS device injecting subdermally versus subcutaneously, but using Enbrel instead of Gadolinium on the particular skin affected by Plaque Psoriasis. Once we have shown ASIS device's consistent performance in Aim 1, then we may assume will deliver another product (Enbrel) into that bloodless space without the need to measure Enbrel's existent in that bloodless space. Using Enbrel instead of Gadolinium, we'll demonstrate the advantages of injecting subdermally over intramuscularly for the same affected skin sites in the same 60 adult subjects.

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Inclusion Criteria in general and for Gadolinium:

- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65

- Genders Eligible for Study: Both

- Accepts Healthy Volunteers: Yes

- Must be outpatient, male or female, of any race, between 18 and 65 years of age.

- Must be able to understand the requirements of the study including maintaining a

diary, and sign informed consent.

- Must be in good general health as determined by investigator.

- If female of childbearing potential, must have negative pregnancy test result at

screening visit and practice reliable method of contraception

- Inclusion Criteria for Plaque Psoriasis in particular:

- Must have chronic moderate to severe plaque psoriasis and be candidates for systemic

therapy or phototherapy.

- Must have psoriasis involving at least 10% of body surface and a minimum PASI score

of 10.

- Patients are limited to low-moderate-strength topical corticosteroids in axillary,

groin, and scalp regions. Exclusion Criteria:

- Exclusion Criteria for Plaque Psoriasis in particular:

- Patients with guttate, erythrodermic, or pustular psoriasis and patients with severe

infections within 4 weeks of screening are excluded from study.

- No concomitant major anti-psoriatic therapies are allowed during the study.

- Has chronic or recurrent infection, has been exposed to tuberculosis, has resided or

traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or has underlying conditions that may predispose them to infection such as advanced or poorly controlled diabetes

Locations and Contacts

Li Nguyen, MD, Phone: (714)-453-7857, Email: dr.li.nguyen@asis-inc.com

Automatic Subdermal Injector System, Inc, Westminster, California 92683, United States; Not yet recruiting
Li Nguyen, MD, Phone: 714-453-7857, Email: dr.li.nguyen@asis-inc.com
Thanh Phung, MD, Phone: (714)-893-1915, Email: thanhphung@idit-inc.com
Li Nguyen, MD, Principal Investigator

Automatic Subdermal Injector System, Inc, Westminster, California 92683, United States

Additional Information

Click here for more information about this study ASIS for Enbrel in Plaque Psoriasis

Related publications:

Fisher CJ Jr, Agosti JM, Opal SM, Lowry SF, Balk RA, Sadoff JC, Abraham E, Schein RM, Benjamin E. Treatment of septic shock with the tumor necrosis factor receptor:Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med. 1996 Jun 27;334(26):1697-702.

Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12.

Bhutani T, Wong JW, Bebo BF, Armstrong AW. Access to health care in patients with psoriasis and psoriatic arthritis: data from National Psoriasis Foundation survey panels. JAMA Dermatol. 2013 Jun;149(6):717-21. doi: 10.1001/jamadermatol.2013.133.

Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80.

Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995 - Status and Review. In: Spilker B, ed. "Quality of Life and Pharmacoeconomics in Clinical Trials." 2nd ed. Philadelphia, PA. Lippincott-Raven 1996;227

Enbrel (etanercept) Product Information http://pi.amgen.com/united_states/enbrel/derm/enbrel_pi

GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID). http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5

Magnevist (gadopentetate dimeglumine) Injection Product Information. http://bayerimaging.com/products/magnevist/safety-information_nsf.php

Starting date: January 2016
Last updated: June 22, 2015

Page last updated: August 23, 2015

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