Trial · NCT02245412
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
NCT02245412, Phase 2, Terminated, Alexion Pharmaceuticals, Inc.; results first posted 2017-10-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease. Trials, record NCT02245412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02245412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
- NCT number
- NCT02245412
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Acute Graft-Versus-Host Disease, GIGVHD
- Interventions
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- First posted
- 2014-09-19
- Last updated
- 2019-01-03
- Results first posted
- 2017-10-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 | Day 28 | The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash \<25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = \>50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = \<500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = \>1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = \>15 mg/dL. |
| Secondary | Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 | Predose up to 72 hours postdose | The Tmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET). Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available. |
| Secondary | PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 | Predose up to 72 hours postdose | The Cmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET). Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available. |
| Secondary | PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 | Predose up to 72 hours postdose | The AUC of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET). Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 | Day 28 | Participants in the mFAS Population - In the 10 mg/kg ALXN1007 once weekly dose group, 1 participant was prematurely discontinued after receiving a single dose due to lack of confirmed GI GVHD. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 | Predose up to 72 hours postdose | PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and pharmacodynamic (PD) data. | hours | MEDIAN |
| SECONDARY | PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 | Predose up to 72 hours postdose | PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data. | ug/mL | MEDIAN |
| SECONDARY | PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 | Predose up to 72 hours postdose | PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data. | h*ug/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 | ALXN1007 10 mg/kg Once Weekly | 10 | Participants | ||
| Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 | ALXN1007 20 mg/kg Once Weekly | 3 | Participants | ||
| Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28 | ALXN1007 20 mg/kg Twice Weekly | 1 | Participants | ||
| Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Tmax Day 1 | 1.033 | Full Range 0.983 to 5.0 | hours |
| Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Tmax Day 28 | 1.03 | Full Range 1.0 to 5.0 | hours |
| Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Tmax Day 49 | 1.25 | Full Range 1.0 to 1.8 | hours |
| PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Cmax Day 1 | 270 | Full Range 156 to 318 | ug/mL |
| PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Cmax Day 28 | 383 | Full Range 283 to 409 | ug/mL |
| PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | Cmax Day 49 | 421 | Full Range 207 to 450 | ug/mL |
| PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 | ALXN1007 10 mg/kg Once Weekly | AUC Day 1 | 13079 | Full Range 7429 to 20113 | h*ug/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | ALXN1007 10 mg/kg Once Weekly | 17 | |
| Treatment Period | STARTED | ALXN1007 20 mg/kg Once Weekly | 6 | |
| Treatment Period | STARTED | ALXN1007 20 mg/kg Twice Weekly | 2 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | ALXN1007 10 mg/kg Once Weekly | 17 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | ALXN1007 20 mg/kg Once Weekly | 6 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | ALXN1007 20 mg/kg Twice Weekly | 2 | |
| Treatment Period | Modified Full Analysis Set (mFAS) | ALXN1007 10 mg/kg Once Weekly | 16 | |
| Treatment Period | Modified Full Analysis Set (mFAS) | ALXN1007 20 mg/kg Once Weekly | 6 | |
| Treatment Period | Modified Full Analysis Set (mFAS) | ALXN1007 20 mg/kg Twice Weekly | 2 | |
| Treatment Period | COMPLETED | ALXN1007 10 mg/kg Once Weekly | 12 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events573
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 | Anaemia | Blood and lymphatic system disorders | ALXN1007 10 mg/kg Once Weekly | 1 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Once Weekly | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Twice Weekly | 0 | 2 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ALXN1007 10 mg/kg Once Weekly | 2 | 17 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Once Weekly | 0 | 6 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Twice Weekly | 0 | 2 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ALXN1007 10 mg/kg Once Weekly | 1 | 17 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Once Weekly | 0 | 6 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ALXN1007 20 mg/kg Twice Weekly | 0 | 2 | |
| other | Lymphopenia | Blood and lymphatic system disorders | ALXN1007 10 mg/kg Once Weekly | 1 | 17 |
1 to 10 of 573Source ClinicalTrials.gov
See all 573 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALXN1007 10 mg/kg Once Weekly | 6 | 17 |
| Total, all-cause mortality | ALXN1007 20 mg/kg Once Weekly | 3 | 6 |
| Total, all-cause mortality | ALXN1007 20 mg/kg Twice Weekly | 1 | 2 |
| Total, other adverse events | ALXN1007 10 mg/kg Once Weekly | 17 | 17 |
| Total, other adverse events | ALXN1007 20 mg/kg Once Weekly | 6 | 6 |
| Total, other adverse events | ALXN1007 20 mg/kg Twice Weekly | 2 | 2 |
| Total, serious adverse events | ALXN1007 10 mg/kg Once Weekly | 13 | 17 |
| Total, serious adverse events | ALXN1007 20 mg/kg Once Weekly | 4 | 6 |
| Total, serious adverse events | ALXN1007 20 mg/kg Twice Weekly | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT02245412
GET https://conductscience.org/api/trials/v1/NCT02245412/flow?page=2