Trial · NCT02745145
Abituzumab in SSc-ILD
NCT02745145, Phase 2, Terminated, EMD Serono Research & Development Institute, Inc.; results first posted 2019-06-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Abituzumab in SSc-ILD. Trials, record NCT02745145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02745145
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abituzumab in SSc-ILD
- NCT number
- NCT02745145
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Systemic Sclerosis-associated Interstitial Lung Disease
- Interventions
- Abituzumab 1500 mg, Abituzumab 500 mg, Placebo
- First posted
- 2016-04-20
- Last updated
- 2019-06-18
- Other registries' IDs
- eudract:2015-005023-11
- Results first posted
- 2019-06-18
- Limitations and caveats
The analysis of outcome measures at Week 104 wasn't conducted as the study was terminated due to the difficulties experienced in identifying participants who meet the eligibility criteria of the trial.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 | Baseline, Week 52 | FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. Change from baseline in fvc at week 52 was reported. |
| Secondary | Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52 | Baseline, Week 52 | Mahler's TDI was an interview-administered instrument that allows participants to assess their level of dyspnea which was assessed by functional impairment, magnitude of task and magnitude of effort. Scores for each subscale range from -3 to +3 so that the TDI focal score ranges from -9 (major deterioration) to +9 (major improvement). For all subscale scores and the TDI focal score a higher value indicates a better outcome. |
| Secondary | Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline, Week 52 | The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the weighted sum of domain scores for symptoms, activity, and impact (0=the best possible score and 100=the worst possible score). A reduction in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life. |
| Secondary | Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Participants With Diffuse Cutaneous Skin Involvement at Baseline | Baseline, Week 52 | The Modified Rodnan Skin Score (mRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. |
| Secondary | Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52 | Baseline, Week 52 | Absolute change from baseline in QLF score at week 52 was calculated as the difference of the QLF score at week 52 minus the QLF score at baseline divided in the region of highest baseline severity at Week 52 .The QLF score itself ranges from 0 to 100, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. |
| Secondary | Overall Survival (OS) | Time from date of randomization until death, assessed up to 2 years | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants. |
| Secondary | Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD]) | upto Week 52 | Clinically Meaningful Progression SSc-ILD was defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (\>=)10%; Relative decrease from baseline in FVC % predicted of \>=5% to less than (\<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted \>=15%. |
| Secondary | Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 2 (SSc Progression Other Than ILD) | upto Week 52 | Clinically Meaningful Progression SSc other than ILD was defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction \<=45%); Pulmonary arterial hypertension requiring treatment. |
| Secondary | Number of Participants With Clinically Meaningful Progression | upto Week 52 | Participants meeting one or both of the below criteria was considered as having clinically meaningful disease progression. Clinically Meaningful SSc-ILD defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (\>=)10%; Relative decrease from baseline in FVC % predicted of \>=5% to less than (\<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted \>=15%. Clinically Meaningful SSc progression other than ILD defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction \<=45%); Pulmonary arterial hypertension requiring treatment. |
| Secondary | Number of Participants With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater Than or Equal to (>=) 10% on 2 or More Consecutive Occasions at Least 4 Weeks Apart | upto Week 52 | FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 | Baseline, Week 52 | Modified intent-to-treat (mITT) population was defined as all randomized participants who received at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted. | milliliters | MEAN |
| SECONDARY | Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52 | Baseline, Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted. | Score on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline, Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted. | Scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Participants With Diffuse Cutaneous Skin Involvement at Baseline | Baseline, Week 52 | mITT diffuse cutaneous systemic sclerosis population from mITT analysis set who had diffuse cutaneous skin involvement at baseline. Here, Overall Number of Participants Analyzed signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg and abituzumab 1500 mg arm dropped out before the analysis was conducted. | Scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52 | Baseline, Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted. | Scores on a scale | MEAN |
| SECONDARY | Overall Survival (OS) | Time from date of randomization until death, assessed up to 2 years | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD]) | upto Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 2 (SSc Progression Other Than ILD) | upto Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Progression | upto Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater Than or Equal to (>=) 10% on 2 or More Consecutive Occasions at Least 4 Weeks Apart | upto Week 52 | mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 | Placebo | -130 | Standard Deviation 56.6 | milliliters | |
| Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52 | Abituzumab 1500 mg | -50 | Standard Deviation NA | milliliters | |
| Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52 | Placebo | 3 | Standard Deviation NA | Score on a scale | |
| Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52 | Abituzumab 1500 mg | 4 | Standard Deviation NA | Score on a scale | |
| Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Placebo | 6.4 | Standard Deviation NA | Scores on a scale | |
| Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Abituzumab 1500 mg | 1.4 | Standard Deviation NA | Scores on a scale | |
| Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Participants With Diffuse Cutaneous Skin Involvement at Baseline | Placebo | 0 | Standard Deviation NA | Scores on a scale | |
| Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52 | Placebo | 6.29 | Standard Deviation 2.638 | Scores on a scale | |
| Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52 | Abituzumab 1500 mg | -2.27 | Standard Deviation NA | Scores on a scale | |
| Overall Survival (OS) | Placebo | Number of deaths | 0 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | Abituzumab 500 Milligrams (mg) | 5 | |
| Overall Study | STARTED | Abituzumab 1500 mg | 9 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Abituzumab 500 Milligrams (mg) | 0 | |
| Overall Study | COMPLETED | Abituzumab 1500 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Abituzumab 500 Milligrams (mg) | 5 | |
| Overall Study | NOT COMPLETED | Abituzumab 1500 mg | 9 |
Source ClinicalTrials.gov
Adverse events258
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 | Placebo | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Abituzumab 500 Milligrams (mg) | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Abituzumab 1500 mg | 1 | 9 | |
| other | Sinus tachycardia | Cardiac disorders | Placebo | 0 | 10 | |
| other | Sinus tachycardia | Cardiac disorders | Abituzumab 500 Milligrams (mg) | 0 | 5 | |
| other | Sinus tachycardia | Cardiac disorders | Abituzumab 1500 mg | 1 | 9 | |
| other | Eye pain | Endocrine disorders | Placebo | 0 | 10 | |
| other | Eye pain | Endocrine disorders | Abituzumab 500 Milligrams (mg) | 0 | 5 | |
| other | Eye pain | Endocrine disorders | Abituzumab 1500 mg | 1 | 9 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 1 | 10 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, all-cause mortality | Abituzumab 500 Milligrams (mg) | 1 | 5 |
| Total, all-cause mortality | Abituzumab 1500 mg | 0 | 9 |
| Total, other adverse events | Placebo | 9 | 10 |
| Total, other adverse events | Abituzumab 500 Milligrams (mg) | 4 | 5 |
| Total, other adverse events | Abituzumab 1500 mg | 8 | 9 |
| Total, serious adverse events | Placebo | 1 | 10 |
| Total, serious adverse events | Abituzumab 500 Milligrams (mg) | 1 | 5 |
| Total, serious adverse events | Abituzumab 1500 mg | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33004536 | DERIVED |
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 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/NCT02745145
GET https://conductscience.org/api/trials/v1/NCT02745145/results?page=2