Trial · NCT02503644
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
NCT02503644, Phase 2, Completed, Inventiva Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis. Trials, record NCT02503644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02503644
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
- NCT number
- NCT02503644
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Inventiva Pharma
- Conditions
- Scleroderma, Diffuse, Diffuse Cutaneous Systemic Sclerosis
- Interventions
- IVA337, Placebo
- First posted
- 2015-07-21
- Last updated
- 2019-03-04
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of skin thickness by the Modified Rodnan Skin Score (MRSS) | 48 weeks | Mean change of the MRSS from baseline |
| Secondary | Response rates based on MRSS improvement | 12, 24, 32, 48 weeks | MRSS response rates: Initial definition: improvers are defined by a reduction ≥5 points and ≥25 % of MRSS; Additional definition: improvers are defined by a reduction ≥ 4 points and ≥ 20% of MRSS based on Quillinan et al. (2014, 2017) |
| Secondary | Overall progression of the disease: defined as absence of rescue therapy and absence of severe organ involvement | 28, 32,40, and 48 weeks | Overall progression of the disease: defined as absence of rescue therapy and absence of severe organ involvement |
| Secondary | Lung function measured by FVC% predicted | 24 and 48 weeks | Change in pulmonary function |
| Secondary | Lung function by cDLCO% predicted | 24 and 48 weeks | Change in pulmonary function |
| Secondary | Scleroderma Health Assessment Questionnaire (SHAQ) | 24 and 48 weeks | Changes in patient reported outcomes |
| Secondary | Gastrointestinal tract symptoms severity and its impact on patients' well-being assessed by the UCLA SCTC GIT | 24 and 48 weeks | Changes in patient reported outcomes |
| Secondary | Patient-reported health status assessed by PROMIS29 | 24 and 48 weeks | Changes in patient reported outcomes |
| Secondary | Physical and mental health assessed by SF36 | 24 and 48 weeks | Changes in patient reported outcomes |
| Secondary | Digital ulcer net burden (defined as total number of ulcers at a certain time point minus number of ulcers at baseline) and proportion of patients who do not develop new ulcers | 12, 24, 32 and 48 weeks | Digital ulcer net burden (defined as total number of ulcers at a certain time point minus number of ulcers at baseline) and proportion of patients who do not develop new ulcers |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02503644
GET https://conductscience.org/api/trials/v1/NCT02503644/registered?page=2