Trial · NCT04200755
Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma
NCT04200755, Phase 2, Completed, University of Cologne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma. Trials, record NCT04200755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04200755
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma
- NCT number
- NCT04200755
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Cologne
- Conditions
- Localized Scleroderma
- Interventions
- Dupilumab 300Mg Solution for Injection, Placebo
- First posted
- 2019-12-16
- Last updated
- 2024-10-26
- Other registries' IDs
- eudract:2019-002036-90
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LoSCAT target lesion | Baseline to End of Treatment Visit, 24 weeks | Treatment response is assessed using the LoSCAT (Localized Scleroderma Cutaneous Assessment Tool). Target lesion will be assessed at Baseline and End of Treatment. Score reduction by 50% after 24 weeks (End of Treatment Visit V14) compared to Baseline Visit (V1) is defined as treatment response. |
| Secondary | mLoSSI all lesions | Baseline to Follow-Up Visit, 48 weeks | Change in mLoSSI (Localized Scleroderma Skin Activity Index) of all existing lesions during treatment, at End of Treatment Visit and during follow-up |
| Secondary | LoSDI all lesions | Baseline to Follow-Up Visit, 48 weeks | Change in LoSDI (Localized Scleroderma Skin Damage Index) of all existing lesions during treatment, at End of Treatment Visit and during follow-up |
| Secondary | Number of lesions | Baseline to Follow-Up Visit, 48 weeks | Count of all existing non-target and new lesions on the entire integument during treatment, at End of Treatment Visit and during follow-up |
| Secondary | DLQI | Baseline to Follow-Up Visit, 48 weeks | Change in DermatoLogy Quality of life Index (DLQI). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
| Secondary | RNAseq | Baseline to End of Treatment Visit, 24 weeks | Gene signature of localized scleroderma after Dupilumab treatment: RNA- seq of tissue biopsies obtained from the lesion (lilac ring, optional: center) before (baseline visit V1) and after treatment (EoT V14) and healthy skin before treatment |
| Secondary | RT-qPCR | Baseline to End of Treatment Visit, 24 weeks | Quantification of change in gene expression of genes identified by RNAseq in tissue of localized scleroderma patients after Dupilumab treatment: RT-qPCR of tissue biopsies obtained from the lesion (lilac ring, optional: center) before (baseline visit V1) and after treatment (End of Treatment Visit V14) and healthy skin before treatment |
| Secondary | Adverse events (AEs) | Baseline to Follow-Up Visit, 48 weeks | Adverse events will be documented throughout the study |
| Secondary | Physical examination | Baseline to Follow-Up Visit, 48 weeks | Physical examination (general appearance including skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, respiratory, cardiovascular, musculoskeletal, and neurological systems) will be documented throughout the study. |
| Secondary | Body weight | Baseline to Follow-Up Visit, 48 weeks | Body weight will be documented throughout the study. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42957460 | 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/NCT04200755
GET https://conductscience.org/api/trials/v1/NCT04200755/registered