Trial · NCT02469857
Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
NCT02469857, Phase 3, Completed, Atox Bio Ltd; results first posted 2021-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections. Trials, record NCT02469857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02469857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
- NCT number
- NCT02469857
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 290 participants, actual
- Lead sponsor
- Atox Bio Ltd
- Conditions
- Necrotizing Soft Tissue Infections, Necrotizing Fasciitis, Fournier's Gangrene
- Interventions
- AB103 0.5 mg/kg, NaCl 0.9%
- First posted
- 2015-06-12
- Last updated
- 2021-10-05
- Results first posted
- 2021-10-05
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | 28 days | NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Secondary | Number of Patients With One or More Adverse Events (AEs) | 28 days | Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs. |
| Secondary | Number of Patients With One or More Serious Adverse Events (SAEs) | 28 days | Number of Patients with One or More Serious Adverse Events (SAEs) During the Study |
| Secondary | Number of Patients With One or More Secondary Infections | 28 days | Number of Patients with One or More Secondary Infections During the Study |
| Secondary | Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 14 days | Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Secondary | Intensive Care Unit (ICU)-Free Days | 28 days | ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28. |
| Secondary | Ventilator-free Days | 28 days | Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28. |
| Secondary | Vasopressor-free Days | 28 days | Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28. |
| Secondary | Hospital Days | 90 days or until end of follow up | Hospital days refers to the number of days a patient spent time in the hospital. |
| Secondary | Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location | 90 days | Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | 28 days | The primary analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification.~A secondary analysis of the primary outcome measure utilized the United States-modified intent-to-treat (US-mITT) analysis population which consisted only of mITT patients enrolled in the United States. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With One or More Adverse Events (AEs) | 28 days | As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With One or More Serious Adverse Events (SAEs) | 28 days | As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With One or More Secondary Infections | 28 days | As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 14 days | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intensive Care Unit (ICU)-Free Days | 28 days | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | days | MEDIAN |
| SECONDARY | Ventilator-free Days | 28 days | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | days | MEDIAN |
| SECONDARY | Vasopressor-free Days | 28 days | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | days | MEDIAN |
| SECONDARY | Hospital Days | 90 days or until end of follow up | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | days | MEDIAN |
| SECONDARY | Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location | 90 days | The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | Reltecimod (AB103) 0.5 mg/kg | mITT Population | 69 | Participants | |
| Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | Placebo | mITT Population | 59 | Participants | |
| Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | Reltecimod (AB103) 0.5 mg/kg | US-mITT Population | 67 | Participants | |
| Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | Placebo | US-mITT Population | 50 | Participants | |
| Number of Patients With One or More Adverse Events (AEs) | AB103 0.5 mg/kg | 104 | Participants | ||
| Number of Patients With One or More Adverse Events (AEs) | Placebo | 96 | Participants | ||
| Number of Patients With One or More Serious Adverse Events (SAEs) | AB103 0.5 mg/kg | 44 | Participants | ||
| Number of Patients With One or More Serious Adverse Events (SAEs) | Placebo | 40 | Participants | ||
| Number of Patients With One or More Secondary Infections | AB103 0.5 mg/kg | 30 | Participants | ||
| Number of Patients With One or More Secondary Infections | Placebo | 32 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Reltecimod (AB103) 0.5 mg/kg | 143 | |
| Overall Study | STARTED | Placebo | 147 | |
| Overall Study | COMPLETED | Reltecimod (AB103) 0.5 mg/kg | 118 | |
| Overall Study | COMPLETED | Placebo | 115 | |
| Overall Study | NOT COMPLETED | Reltecimod (AB103) 0.5 mg/kg | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events142
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Reltecimod (AB103) 0.5 mg/kg | 8 | 143 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 6 | 147 | 7 |
| other | Atrial fibrillation | Cardiac disorders | Reltecimod (AB103) 0.5 mg/kg | 7 | 143 | 7 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 8 | 147 | 8 |
| other | Diarrhea | Gastrointestinal disorders | Reltecimod (AB103) 0.5 mg/kg | 6 | 143 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 8 | 147 | 8 |
| other | Pneumonia | Infections and infestations | Reltecimod (AB103) 0.5 mg/kg | 5 | 143 | 5 |
| other | Pneumonia | Infections and infestations | Placebo | 11 | 147 | 11 |
| serious | Acute myocardial infarction | Cardiac disorders | Reltecimod (AB103) 0.5 mg/kg | 2 | 143 | 2 |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo | 3 | 147 | 3 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reltecimod (AB103) 0.5 mg/kg | 24 | 143 |
| Total, all-cause mortality | Placebo | 29 | 147 |
| Total, other adverse events | Reltecimod (AB103) 0.5 mg/kg | 24 | 143 |
| Total, other adverse events | Placebo | 25 | 147 |
| Total, serious adverse events | Reltecimod (AB103) 0.5 mg/kg | 44 | 143 |
| Total, serious adverse events | Placebo | 40 | 147 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32657946 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons16
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AB103 0.5 mg/kg vs Placebo: Number of Patients With One or More Adverse Events (AEs) | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Deaths From Day 0 Through Day 90 | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock) | Trial comparisons |
| AB103 0.5 mg/kg vs Placebo: Number of Patients With One or More Secondary Infections | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5 | Trial comparisons |
| AB103 0.5 mg/kg vs Placebo: Number of Patients With One or More Serious Adverse Events (SAEs) | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Deaths After Day 14 Through Day 90 | Trial comparisons |
| Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | Trial comparisons |
1 to 10 of 16
See all 16 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02469857
GET https://conductscience.org/api/trials/v1/NCT02469857/results?page=2