Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

NCT04541550 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: INT-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, dose-escalation study enrolling 15 participants. There are 3 cohorts:

1. 1.Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline)
2. 2.Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline)
3. 3.Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Total number of Adverse Events

  6 months

Study Arms (3)

Low Dose AMP-001

EXPERIMENTAL

12.5 mg AMP-001 in 3 ml Saline

Drug: AMP-001 Low Dose

Medium Dose AMP-001

EXPERIMENTAL

25 mg AMP-001in 3 ml Saline

Drug: AMP-001 Medium Dose

High Dose AMP-001

EXPERIMENTAL

50 mg AMP-001 in 3 ml Saline

Drug: AMP-001 High Dose

Interventions

AMP-001 Low Dose DRUG

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Also known as: 12.5 mg AMP-001

Low Dose AMP-001

AMP-001 Medium Dose DRUG

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Also known as: 25 mg AMP-001

Medium Dose AMP-001

AMP-001 High Dose DRUG

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Also known as: 50 mg AMP-001

High Dose AMP-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Can understand the nature of the procedure, and provide, or have a legal representative provide, a written informed consent.
• Clinically diagnosed with Hidradenitis Suppurativa characterized as Hurley Score, Stage II or Stage III.
• History of standard-of-care supportive treatment failure with corticosteroids and/or antibiotics within 30 days before the baseline visit.
• Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit.
• No prior history of a biologic product or Humira for the treatment of Hidradenitis Suppurativa.

You may not qualify if:

• Intolerance or unwillingness to participate in all procedure(s) or medication(s) required of this protocol.
• Diagnosis or reported history of any of the folding conditions:
• Uncontrolled Diabetes Mellitus (HbA1c ≥9);
• Severe Morbid Obesity (BMI≥40);
• Chronic heart, renal, or hepatic disease;
• Neurodegenerative debilitating conditions, and
• Cancer.
• The participant is currently receiving or has received within 3 months before enrollment, medications or treatments that are known to affect the wound healing process, including but not limited to: chronic systemic steroid intake, history of recent changes in the participant's tissue integrity (i.e., thin, fragile skin with multiple hematomas or previous lacerations), current use of immune-suppressive drugs, radiation therapy, immunomodulating medications, and chemotherapy.
• The participant has received HS micronized amnion therapy in the last 90 days.
• Systolic blood pressure greater than 190 or less than 90 mmHg.
• Diastolic blood pressure greater than 105 or less than 50 mmHg.
• Early, symptomatic autonomic dysfunction.
• Abuse of prescription drugs, illegal substances, and/or alcohol.
• Females who are pregnant, nursing, or of childbearing potential and not using a reliable birth control method (such as, female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge or gels, in addition to male use of a condom) or the female should be using prescribed "birth control" pills, injections, or implants. or who intend to become pregnant during their participation in the study.
• Clinically significant abnormal laboratory values at the time of the screening or baseline visit.

Sponsors & Collaborators

• IntegoGen, LLC: lead

Study Sites (1)

West Houston Dermatology Laser and Skin Care Center

Houston, Texas, 77082, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Stephen Mahoney, MD

  West Houston Dermatology Laser and Skin Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)