Colostomy StomaPhase 2NCT02544061
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
A Phase 2 study testing NM-IL-12 in people with Colostomy Stoma, run by Neumedicines Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colostomy Stoma
- What is being tested?
- NM-IL-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2016to 28 Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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,
- Neutrophils > 2000 cells/µL,
- Lymphocytes > 1000 cells/µL,
- Platelets > 140,000 /µL.
- All other clinical chemistry and coagulation laboratory values at enrollment must be either within the reference range or considered to be not clinically significant by the investigator and sponsor. Hematological laboratory values that are outside of the reference range must be reported to be above the upper limit of normal and not be reported as clinically significant.
Who cannot join
- 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.
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- 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.
- Known medical history (carrier or disease) of human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B, or Hepatitis C, or other diseases known to be autoimmune in origin.
- Known medical history of tuberculosis or liver cirrhosis.
- Current or prior treatment with growth factors or hyperbaric therapy in the last 30 days preceding study day 1.
- History of sensitivity to the study medication, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical/research monitor, contraindicates their participation.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or serious active infection (not including eligible surgical wounds), symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, metastatic cancer, chronic obstructive pulmonary disease (COPD; (using home oxygen therapy).
- Insulin-requiring diabetes.
- BMI > 40.
- Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety of the study drug, or prevent compliance with the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
University of Florida
Gainesville, Florida, 32610
Washington University in St. Louis
St Louis, Missouri, 63110-1010
About this study
Official title: A Phase IIa Open-label, Randomized Study to Compare the Safety, Tolerability and Pharmacokinetics (PK) of NM-IL-12 (rHuIL-12) to Standard of Care in Subjects With Open Surgical Wounds Following Colostomy Takedown
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.
Read the detailed description
This is a phase IIa open-label, randomized study to compare the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of NM-IL-12 (rHuIL-12) to standard of care in subjects with open surgical wounds following colostomy takedown allowed to heal by secondary intention.
- Conditions
- Colostomy Stoma
- Being tested
- NM-IL-12, Placebo
- Keywords
- NM-IL-12, HemaMax, Safety, Stoma Takedown, Wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM-IL-12Biological
Also called rHu-IL12, HemaMax
single 12 µg unit subcutaneous (SC) dose of NM-IL-12
PlaceboDrug
single subcutaneous dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
No evidence of infection
Measured: 42 Days
Median time to greater than 50% surgical stoma site (wound) closure relative to the stoma site (wound) size at enrollment.
Median days to greater than 50% closure of the original wound
Measured: 42 Days
Area under the plasma concentration versus time curve (AUC) of NM-IL-12
Area under the plasma concentration versus time curve (AUC) of NM-IL-12
Measured: 1 week
Peak Plasma Concentration (Cmax) of NM-IL-12
Peak Plasma Concentration (Cmax) of NM-IL-12
Measured: 1 week
Immunogenicity of HemaMax (anti-NM-IL-12 antibodies as a measure of immunogenicity)
anti-NM-IL-12 antibodies as a measure of immunogenicity
Measured: 3 months
Pharmacodynamics of NM-IL-12, Peak Plasma Concentration (Cmax) of IFN-g
Peak Plasma Concentration (Cmax) of IFN-g
Measured: 1 week
Pharmacodynamics of NM-IL-12, Area under the plasma concentration versus time curve (AUC) of IFN-g
Area under the plasma concentration versus time curve (AUC) of IFN-g
Measured: 1 week
Pharmacodynamics of NM-IL-12, Area under the plasma concentration versus time curve (AUC) of IP-10
Area under the plasma concentration versus time curve (AUC) of IP-10
Measured: 1 week
Pharmacodynamics of NM-IL-12, Peak Plasma Concentration (Cmax) of IP-10
Peak Plasma Concentration (Cmax) of IFN-g
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start1 Mar 2016
- Primary completion31 Oct 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colostomy StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neumedicines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Grant V Bochicchio, MD, MPH (GB), Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544061
- Sponsor's protocol ID
- 2015-SWI-004
- Other IDs
- W81XWH-15-2-009
- Status last verified
- Nov 2018
- First submitted
- 3 Sep 2015
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24725395
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Open-label, Randomized Study to Compare the Safety, Tolerability and Pharmacokinetics (PK) of NM-IL-12 (rHuIL-12) to Standard of Care in Subjects With Open Surgical Wounds Following Colostomy Takedown
- ClinicalTrials.gov ID
- NCT02544061
- Acronym / sponsor ID
- 2015-SWI-004
- Conditions
- Colostomy Stoma
- Keywords
- NM-IL-12, HemaMax, Safety, Stoma Takedown, Wound closure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Neumedicines Inc.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase IIa open-label, randomized study to compare the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of NM-IL-12 (rHuIL-12) to standard of care in subjects with open surgical wounds following colostomy takedown allowed to heal by secondary intention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NM-IL-12 plus Standard of Care (SOC) | Experimental | Biological: NM-IL-12Single 12 µg unit subcutaneous dose of NM-IL-12 plus SOC. Standard wound management: wet to dry dressing care and perioperative antimicrobial therapy |
| Placebo plus SOC | Placebo comparator | Drug: PlaceboSingle subcutaneous dose of placebo plus SOC Standard wound management: wet to dry dressing care and perioperative antimicrobial therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- 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):
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM-IL-12Also: rHu-IL12, HemaMaxsingle 12 µg unit subcutaneous (SC) dose of NM-IL-12 | Biological | NM-IL-12 plus Standard of Care (SOC) |
| Placebosingle subcutaneous dose | Drug | Placebo plus SOC |
Primary outcome
Safety and tolerability of NM-IL-12 (Number of subjects with adverse events)
Time frame: 42 Days
Number of subjects with adverse events as a measure of safety and tolerability
9 secondary outcomes
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.
Time frame: 42 Days
Median time to greater than 50% surgical stoma site (wound) closure relative to the stoma site (wound) size at enrollment.
Time frame: 42 Days
Area under the plasma concentration versus time curve (AUC) of NM-IL-12
Time frame: 1 week
Peak Plasma Concentration (Cmax) of NM-IL-12
Time frame: 1 week
Immunogenicity of HemaMax (anti-NM-IL-12 antibodies as a measure of immunogenicity)
Time frame: 3 months
Pharmacodynamics of NM-IL-12, Peak Plasma Concentration (Cmax) of IFN-g
Time frame: 1 week
Pharmacodynamics of NM-IL-12, Area under the plasma concentration versus time curve (AUC) of IFN-g
Time frame: 1 week
Pharmacodynamics of NM-IL-12, Area under the plasma concentration versus time curve (AUC) of IP-10
Time frame: 1 week
Pharmacodynamics of NM-IL-12, Peak Plasma Concentration (Cmax) of IP-10
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Results publication: PubMed 24725395Gokhale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant V Bochicchio, MD, MPH (GB) principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NM-IL-12 in people with Colostomy Stoma, run by Neumedicines Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of NM-IL-12 (Number of subjects with adverse events) (time frame: 42 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.