Trial · NCT05879458
Ritlecitinib in CTCL
NCT05879458, Phase 2, Terminated, Icahn School of Medicine at Mount Sinai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ritlecitinib in CTCL. Trials, record NCT05879458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05879458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ritlecitinib in CTCL
- NCT number
- NCT05879458
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- CTCL, Mycosis Fungoides, Sezary Syndrome
- Interventions
- Ritlecitinib
- First posted
- 2023-05-30
- Last updated
- 2025-07-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Modified Severity Weighted Assessment Tool (mSWAT) | Baseline and Week 24 | Change in Modified Severity Weighted Assessment Tool (mSWAT) at Week 24 from baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Change in Modified Severity Weighted Assessment Tool (mSWAT) | Baseline and at each visit from week 2 to week 48 / EOS except for week 24 | Change in Modified Severity Weighted Assessment Tool (mSWAT) at each visit from baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Treatment Emergent Adverse Events | up to Week 48/EOS | Incidence and severity of treatment-emergent adverse events |
| Secondary | Number of Serious Adverse Events | up to Week 48/EOS | Number of serious adverse events (SAE) leading to discontinuation |
| Secondary | Number of Adverse Events | up to Week 48/EOS | Number of Adverse events (AE) leading to discontinuation |
| Secondary | Number of clinically significant abnormalities in vital signs | up to Week 48/EOS | Number of clinically significant abnormalities in any vital signs |
| Secondary | Number of clinically significant abnormalities in clinical laboratory values | up to Week 48/EOS | Number of clinically significant abnormalities in any clinical laboratory values |
| Secondary | Change in Percentage of patients achieving 50% or greater improvement in mSWAT score | Baseline and at each visit from week 2 to week 48 / EOS | Change in Percentage of patients achieving 50% or greater improvement in mSWAT score (mSWAT50) at every visit as compared to baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Change in Global Response Score | Baseline and at each visit from week 2 to week 48 / EOS | Change in Global Response Score at each vist as compared to baseline. Percentage of patients achieving complete response (CR: 100% improvement), partial response (PR: 50% to 99% reduction from the baseline score), stable disease (SD: \<25% increase to \<50% clearance from baseline), and progressive disease (\>25% worsening above the baseline score) in skin |
| Secondary | Absolute change of health-related quality of life (Skindex-29) | Baseline and at each visit from week 2 to week 48 / EOS | Absolute change of health-related quality of life (Skindex-29 - questionnaire regarding skin conditions) from Baseline up to Week 48. Skindex29 is a 30 question survey that measures quality of life. It is scored from 1-Never to 5-All the time. Full scale from 30-150. The lower the score, the better the quality of life. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT05879458
GET https://conductscience.org/api/trials/v1/NCT05879458/registered