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Biological

sPGA 50 n(%) for Psoriasis (ASISinPP Trial)

Phase 1 & 2
Waitlist Available
Led By Thanh Phung,, MD
Research Sponsored by ASIS Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genders Eligible for Study: Both
Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ASISinPP Trial 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.

Eligible Conditions
  • Psoriasis

ASISinPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ASISinPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Secondary outcome measures
Efficacy of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis.
Other outcome measures
Adverse Reactions of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis

ASISinPP Trial Design

13Treatment groups
Experimental Treatment
Group I: sPGA 50 n(%)Experimental Treatment6 Interventions
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.
Group II: PASI 75 n(%)Experimental Treatment6 Interventions
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.
Group III: For Right Upper ArmExperimental Treatment1 Intervention
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.
Group IV: For Left Upper ArmExperimental Treatment1 Intervention
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.
Group V: Adverse Reactions with Nervous systemExperimental Treatment2 Interventions
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.
Group VI: Adverse Reactions with MalignanciesExperimental Treatment2 Interventions
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.
Group VII: Adverse Reactions with InfectionsExperimental Treatment2 Interventions
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.
Group VIII: Adverse Reactions with ImmunogenicityExperimental Treatment2 Interventions
Immunogenicity as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Group IX: Adverse Reactions with Heart failureExperimental Treatment2 Interventions
Heart failure as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Group X: Adverse Reactions with AutoantibodiesExperimental Treatment2 Interventions
Autoantibodies, Lupus-like syndrome, autoimmune hepatitis, as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Group XI: Adverse Reactions Blood/low blood countsExperimental Treatment2 Interventions
Blood problems/low blood counts as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Group XII: Adverse Reactions Allergic ReactionsExperimental Treatment2 Interventions
Allergic Reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Group XIII: Adverse Injection site reactionsExperimental Treatment2 Interventions
Injection site reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadolinium
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ASIS CorporationLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Thanh Phung,, MDPrincipal InvestigatorAUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
1 Previous Clinical Trials
60 Total Patients Enrolled
Li Nguyen, MDPrincipal InvestigatorAUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
3 Previous Clinical Trials
180 Total Patients Enrolled

Frequently Asked Questions

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~7 spots leftby Mar 2025