ASIS for Enbrel in Plaque Psoriasis

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.

Conditions

• Plaque Psoriasis.

Interventions

DRUG

Gadolinium

For Left Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

DRUG

Gadolinium

For Left Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

DRUG

Gadolinium

For Left Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

DRUG

Efficacy of Enbrel subcutaneously at Week 12

sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

Efficacy of Enbrel subcutaneously at Week 24

sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

Efficacy of Enbrel subcutaneously at Week 36

sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

Efficacy of Enbrel subdermally at Week 12

sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

Efficacy of Enbrel subdermally at Week 24

sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

Efficacy of Enbrel subdermally at Week 36

sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline. The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over \< 5% of the plaque.

DRUG

PASI 75 n(%) subcutaneously at Week 12

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

PASI 75 n(%) subcutaneously at Week 24

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

PASI 75 n(%) subcutaneously at Week 36

PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

PASI 75 n(%) subdermally at Week 12

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

PASI 75 n(%) subdermally at Week 24

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

PASI 75 n(%) subdermally at Week 36

PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

DRUG

Adverse Reactions of Enbrel subcutaneously

Adverse Reactions of Enbrel subcutaneously at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

DRUG

Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions of Enbrel subdermally at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

DRUG

Gadolinium

For Right Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

DRUG

Gadolinium

For Right Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

DRUG

Gadolinium

For Right Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Sponsors & Collaborators

• ASIS Corporation

  lead INDUSTRY

Principal Investigators

• Li Nguyen, MD · AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

• Thanh Phung,, MD · AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-06-30

Completion

2017-06-30

Countries

• United States

Study Locations