ASIS for Enbrel in Plaque Psoriasis

NCT02112097 | Unknown Phase 1 DMC

• 2 other identifiers: NCTAR066986R44AR066986
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Keywords

Plaque Psoriasis.; Subdermal bloodless space; Subdermal injection; Subcutaneous injection; Injectable electromyography needle; Electrical stimulation; MRI with Gadolinium

Outcome Measures

Primary Outcomes (1)

• Relative Prolongation Ability Score for Gadolinium subdermally injected.

  Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Plaque Psoriasis (involving at least 10% of body surface and a minimum Psoriasis Area \& Severity Index (PASI) score of 10), just for the particular plaque skin area. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %.This approximation can only work if the variables are minimized to the same population with Plaque Psoriasis, and the particular plaque skin area. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, Plaque Psoriasis will be very valuable indicators for us to modify the Enbrel dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.

  6 months

Secondary Outcomes (1)

• Efficacy of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis.

  12 months

Other Outcomes (1)

• Adverse Reactions of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis

  12 months

Study Arms (13)

For Left Upper Arm

EXPERIMENTAL

For Left Upper Arm Total Persistent % subdermally, For Left Upper Arm Total Persistent % subcutaneously, and For Left Upper Arm Relative Prolongation Ability Score. 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

EXPERIMENTAL

For Right Upper Arm Total Persistent % subdermally, For Left Upper Arm Total Persistent % subcutaneously, and For Left Upper Arm Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

sPGA 50 n(%)

EXPERIMENTAL

sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, Efficacy of Enbrel subcutaneously at Week 24, and Efficacy of Enbrel subcutaneously at Week 36 vs. Efficacy of Enbrel subdermally at Week 12, Efficacy of Enbrel subdermally at Week 24, and Efficacy of Enbrel subdermally at Week 36. sPGA 50 n(%) "clear" or "minimal" is the % of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and % of patients with a reduction of PASI of at least 50% from baseline.

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

PASI 75 n(%)

EXPERIMENTAL

PASI 75 n(%) Response to treatment defined as the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI, as PASI 75 n(%) subcutaneously at Week 12, PASI 75 n(%) subcutaneously at Week 24, and PASI 75 n(%) subcutaneously at Week 36 vs. PASI 75 n(%) subdermally at Week 12, PASI 75 n(%) subdermally at Week 24, and PASI 75 n(%) 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

Adverse Injection site reactions

EXPERIMENTAL

Injection site reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Heart failure

EXPERIMENTAL

Heart failure as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions Allergic Reactions

EXPERIMENTAL

Allergic Reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions Blood/low blood counts

EXPERIMENTAL

Blood problems/low blood counts as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Nervous system

EXPERIMENTAL

Nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes, as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Infections

EXPERIMENTAL

Infections (upper respiratory infection, pyelonephritis, bronchitis, septic osteomyelitis, wound infection, pneumonia, foot abscess, leg ulcer), as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Malignancies

EXPERIMENTAL

Malignancies (lymphoma, basal \& squamous skin cancer, non-cutaneous solid tumor, \& Wegener's granulomatosis), as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Immunogenicity

EXPERIMENTAL

Immunogenicity as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Adverse Reactions with Autoantibodies

EXPERIMENTAL

Autoantibodies, Lupus-like syndrome, autoimmune hepatitis, as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.

Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

Interventions

Gadolinium DRUG

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.

Also known as: Gadolinium Magnevist® (gadopentetate dimeglumine)

For Left Upper Arm; For Right Upper Arm

Efficacy of Enbrel subcutaneously at Week 12 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

Efficacy of Enbrel subcutaneously at Week 24 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

Efficacy of Enbrel subcutaneously at Week 36 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

Efficacy of Enbrel subdermally at Week 12 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

Efficacy of Enbrel subdermally at Week 24 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

Efficacy of Enbrel subdermally at Week 36 DRUG

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.

Also known as: Enbrel (etanercept)

sPGA 50 n(%)

PASI 75 n(%) subcutaneously at Week 12 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

PASI 75 n(%) subcutaneously at Week 24 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

PASI 75 n(%) subcutaneously at Week 36 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

PASI 75 n(%) subdermally at Week 12 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

PASI 75 n(%) subdermally at Week 24 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

PASI 75 n(%) subdermally at Week 36 DRUG

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.

Also known as: Enbrel (etanercept)

PASI 75 n(%)

Adverse Reactions of Enbrel subcutaneously DRUG

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.

Also known as: Enbrel (etanercept)

Adverse Injection site reactions; Adverse Reactions Allergic Reactions; Adverse Reactions Blood/low blood counts; Adverse Reactions with Autoantibodies; Adverse Reactions with Heart failure; Adverse Reactions with Immunogenicity; Adverse Reactions with Infections; Adverse Reactions with Malignancies; Adverse Reactions with Nervous system

Adverse Reactions of Enbrel subdermally at Week 36 DRUG

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.

Also known as: Enbrel (etanercept)

Adverse Injection site reactions; Adverse Reactions Allergic Reactions; Adverse Reactions Blood/low blood counts; Adverse Reactions with Autoantibodies; Adverse Reactions with Heart failure; Adverse Reactions with Immunogenicity; Adverse Reactions with Infections; Adverse Reactions with Malignancies; Adverse Reactions with Nervous system

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ASIS Corporation: lead

Study Sites (2)

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Related Publications (8)

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  PMID: 9817107 BACKGROUND

• 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.

  PMID: 23783152 BACKGROUND

• 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. No abstract available.

  PMID: 980495 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

Related Links

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

MeSH Terms

Interventions

Gadolinium; Gadolinium DTPA; Etanercept

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Li Nguyen, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

  PRINCIPAL INVESTIGATOR

• Thanh Phung,, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Nguyen, MD

CONTACT

(714)-453-7857; dr.li.nguyen@asis-inc.com

Thanh Phung, MD

CONTACT

714-893-1915; thanhphung@idit-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (2)