ASIS for Enbrel in Plaque Psoriasis

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ASIS Corporation
• Treatments: Autoantibodies; Etanercept

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