NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds

NCT02544061 | Completed Phase 2

• 2 other identifiers: 2015-SWI-004W81XWH-15-2-009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.

Conditions

Colostomy Stoma

Keywords

NM-IL-12, HemaMax, Safety, Stoma Takedown, Wound closure

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of NM-IL-12 (Number of subjects with adverse events)

  Number of subjects with adverse events as a measure of safety and tolerability

  42 Days

Secondary Outcomes (9)

• Incidence of surgical site infections at the midline site (wound) and at the stoma site (wound) that occur within the period from surgery through postop day 42.

  42 Days

• Median time to greater than 50% surgical stoma site (wound) closure relative to the stoma site (wound) size at enrollment.

  42 Days

• Area under the plasma concentration versus time curve (AUC) of NM-IL-12

  1 week

• Peak Plasma Concentration (Cmax) of NM-IL-12

  1 week

• Immunogenicity of HemaMax (anti-NM-IL-12 antibodies as a measure of immunogenicity)

  3 months

Study Arms (2)

NM-IL-12 plus Standard of Care (SOC)

EXPERIMENTAL

Single 12 µg unit subcutaneous dose of NM-IL-12 plus SOC. Standard wound management: wet to dry dressing care and perioperative antimicrobial therapy

Biological: NM-IL-12

Placebo plus SOC

PLACEBO COMPARATOR

Single subcutaneous dose of placebo plus SOC Standard wound management: wet to dry dressing care and perioperative antimicrobial therapy

Drug: Placebo

Interventions

NM-IL-12 BIOLOGICAL

single 12 µg unit subcutaneous (SC) dose of NM-IL-12

Also known as: rHu-IL12, HemaMax

NM-IL-12 plus Standard of Care (SOC)

Placebo DRUG

single subcutaneous dose

Placebo plus SOC

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo colostomy reversal where the midline wound is closed and the stoma site (wound) is kept open to heal by secondary intention at the time of operation but expected to close between 4 and 6 weeks (per the judgment of the investigator).
• Able to receive the dose of study drug within 24-36 hours post-operatively and demonstrate stable vital signs without unresolved major organ failure/dysfunction requiring critical care/monitoring for at least 24 hours prior to receiving study drug.
• Agree to use accepted highly effective methods of birth control (defined as one that results in a low failure rate (i.e., \<1% per year when used consistently and correctly) and continue for 3 months following receipt of study drug:
• Sexual abstinence (males and females),
• Vasectomized partner (females),
• Condom with spermicide (males) in combination with another non-hormonal barrier method (females
• Females on hormonal birth control should be on these medications for at least 3 years without complications.
• Agree to use accepted highly effective methods of birth control (defined as one that results in a low failure rate (i.e., \<1% per year when used consistently and correctly):
• Sexual abstinence (males and females),Vasectomized partner (females),
• Condom with spermicide (males) in combination with another non-hormonal barrier method (females), must agree to use for at least 3 months following receiving the study drug.
• Females on hormonal birth control should be on these medications for at least 3 years without complications.
• Surgically sterile (does not have a uterus or has had bilateral tubal ligation) or post-menopausal (no menstrual period for a minimum of 1 year) (females).
• A negative serum pregnancy test at the time of enrollment into the study for women of childbearing potential.
• Laboratory values for white blood cells (WBCs), neutrophils, lymphocytes and platelets prior to study drug administration on Day 1 as shown below:
• WBCs \> 3500 cells/µL,

You may not qualify if:

• Concurrent infections of unremovable prosthetic materials (e.g., permanent cardiac pacemaker battery packs, or joint replacement prostheses).
• Undergoing a significant major planned concomitant surgical procedure other than hysterectomy or receiving antibiotic therapy within the week (7 days) prior to the date of surgery other than perioperative antibiotic therapy.
• Preoperative evaluation that suggests an intra-abdominal process that might preclude full closure of the skin by secondary intention.
• Treatment (e.g., chemotherapy, radiation) for cancer in the last 3 months.
• Concomitant use of systemic steroid hormones, i.e. \> 10 mg/day prednisone or equivalent.
• Concomitant use of any immunosuppressive or immunomodulatory drugs.
• History of Crohn's disease or Ulcerative colitis.
• Known history of drug or alcohol abuse within the past year. A positive screening urine toxicology will also exclude patients from this study.
• Medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• Preoperative prothrombin time (PT), ALT, AST, and creatinine \> 1.5 times upper limit of normal.
• Lactating females.
• Postsurgical life expectancy ≤ 60 days, in the investigator or sponsor's opinion.
• Refusal to accept medically indicated blood products.
• Participation within 30 days before the start (dosing) of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
• Presence of prosthetic cardiac valve.

Sponsors & Collaborators

• Neumedicines Inc.: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (3)

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110-1010, United States

Location

Related Publications (1)

• Gokhale MS, Vainstein V, Tom J, Thomas S, Lawrence CE, Gluzman-Poltorak Z, Siebers N, Basile LA. Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects. Exp Hematol Oncol. 2014 Apr 11;3(1):11. doi: 10.1186/2162-3619-3-11.

  PMID: 24725395 RESULT

MeSH Terms

Interventions

Interleukin-12 Subunit p35

Intervention Hierarchy (Ancestors)

Interleukin-12; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Grant V Bochicchio, MD, MPH (GB)

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 9, 2015
• Study Start: March 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: February 28, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)