CTCLPhase 2NCT05879458
Ritlecitinib in CTCL
A Phase 2 study testing Ritlecitinib in people with CTCL and Mycosis Fungoides, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous T-Cell Lymphoma (CTCL). CTCL is a rare type of cancer that starts in the white blood cells and eventually can result in rashes or tumors in the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTCL, Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- Ritlecitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 25 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at time of enrollment
- CTCL >10% BSA involvement (stage IB-IVA by ISCL/EORTC staging criteria), previously confirmed by histopathology
- CTCL subtypes eligible for this study include Mycosis fungoides and its subtypes, as well as Sézary Syndrome.
- Failure of at least 2 skin-directed (ISCL/EORTC stage IB-IIA, i.e. early stage disease) or systemic treatments (ISCL/EORTC stage IIB-IVA, i.e. late stage disease) due to progression or toxicity as assessed by the prescribing physician or by the principal investigator, or insufficient response to established skin-directed or systemic treatments.
- Patients with documented CD30-positive CTCL must have previously received or be intolerant to brentuximab vedotin.
- Adequate hematological (Hb>9.0g/dl, absolute neutrophil count >1200/ul, platelets >75x10^9/L, absolute [non-malignant] lymphocyte count >800/ul), hepatic (AST and ALT <2x times upper limit of normal), and renal function (eGFR [CKD-EPI creatinine equation >50mL/min/1.73m2)
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- ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
- Ability to take oral medication without crushing, dissolving or chewing tablets
- Ability to understand and the willingness to sign a written informed consent
- In the investigator's opinion, the patient has the ability to communicate satisfactorily with the investigator and the study team, to participate fully in the study, and comply with all requirements
Who cannot join
- History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
- Immunosuppressed by previous (within 4 weeks) or current systemic cytotoxic therapies, as evidenced by recurrent skin or systemic infections
- Pregnant or breast-feeding women
- Unwillingness or inability to use a contraception method during the time of participation in the trial.
- Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class III or IV; unstable angina pectoris within 6 months of study enrollment; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
- Previous or concurrent cancer that is distinct in primary site or histology form CTCL, except curatively treated basal or squamous cell carcinoma of the skin, and curatively treated malignant melanoma stage 0-1A with a low risk of recurrence/metastasis as per assessment of the investigator, cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1)
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- Known HIV infection
- Infected with Hepatitis B or Hepatitis C viruses
- Patients with history of either untreated or inadequately treated latent or active TB infections/currently being treated for active TB.
- Recent (within 21 days before baseline) major surgery
- Patients who have history of single episode of disseminated HZ or disseminated HS or recurrent (> 1 episode of) localized dermatomal HZ should be excluded.
- Less than 28 days have elapsed since last radiation therapy, phototherapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment-related toxicity as defined in discontinuation criteria.
- Less than 3 months have elapsed since last oral JAK inhibitors and/or less than 4 weeks have elapsed since last topical JAK inhibitor.
- Glucocorticosteroids when used systemically; the use of nasal and inhaled glucocorticosteroids will be allowed PRN; the use of topical glucocorticosteroids (low to mid-potency) will only be allowed when given at a stable dose >4 weeks
- Prior treatment with other concomitant investigational agents
- Hypersensitivity or allergic reaction to compounds related to JAK inhibitors
- Treatment with medication that might interfere with blood levels or have a major impact on the clinical readout of the study drug, as per discretion of the study investigator; best supportive care will be allowed at the discretion of the investigator (e.g. anti-emetics, skin care, pain medication, anti-thrombotic agents, herpes zoster prophylaxis)
- Any gastrointestinal or metabolic condition that could interfere with the absorption of the oral medication
- Ongoing other MF-directed treatments (such as topical corticosteroids and topical bexarotene) unless stable over a period of one month
- Active alcohol and/or drug abuse
- History of thrombosis/thromboembolic event, known coagulopathy
- Additional skin disease that might interfere with MF clinical assessments
- Patient has received a live attenuated vaccine ≤ 30 days prior to study screening
- Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive.
- Patients who have received prohibited drugs that are CYP3A inducers within a 28 day or 5 half-lives (whichever is longer) period prior to the first dose of study intervention.
- Patients with ALCL or other forms of CTCL other than MF or Sézary Syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Single-center, Single-arm, Open-label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib (PF-06651600) in Patients With Cutaneous T Cell Lymphomas
The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous T-Cell Lymphoma (CTCL). CTCL is a rare type of cancer that starts in the white blood cells and eventually can result in rashes or tumors in the skin. This study includes a 24 week Treatment Period and a 24 week Follow-up Period. This study will involve physical examinations, visual assessments, laboratory tests, PET-CT scans, electrocardiograms, photographs of your skin, skin biopsies, and hearing tests.
Read the detailed description
After providing informed consent, patients will be assessed for study eligibility at the Screening visit (day -28 to day -1) which includes: assessment of inclusion/exclusion criteria; targeted physical examination (including vital signs); mSWAT scoring and disease staging; electrocardiogram (ECG); review of medical history and concomitant medications as well as prior medications/treatments; and serum pregnancy test (if applicable). Laboratory tests will be performed for Complete Blood Count (CBC) with differentials (basophils, eosinophils, lymphocytes, monocytes, neutrophils), serum chemistry including albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, creatine kinase, potassium, sodium, total bilirubin, LDH, viral surveillance panel (EBV, CMV, HSV1, HSV2, and VZV), as well as hepatitis B surface antigen (HBsAg), HBcAb, hepatitis C antibody, and undergo testing for human immunodeficiency virus (HIV). Urinalysis will be performed. Patients will also undergo tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) testing. Patients will also undergo flow cytometric analyses and TCR rearrangement studies of peripheral blood to monitor potential CTCL blood involvement. CT scans with PET (positron emission tomography) scans will be performed within 4 weeks before baseline to help establish or confirm peripheral lymph node size and assign TNM classification, or at any time if internal involvement is suspected by the investigator.
Patients who meet eligibility criteria (meeting all inclusion and no exclusion criteria) will undergo Baseline / Day 0 assessments. These assessments include vital signs and targeted physical examination, mSWAT scoring, clinical disease staging, questionnaires, clinical photography, urine pregnancy test (if applicable), and blood collection for chemistry, hematology, mechanistic studies, baseline for drug levels, blood DNA analysis, blood RNA analysis, and blood proteomic analysis. Two skin biopsies will be obtained (one from an involved area and one from an adjacent uninvolved area). Concomitant medications and any adverse events will be assessed.
Patients will then receive the first oral dose (200mg) of ritlecitinib. Patients will continue to receive the study drug QD through Week 24.
Patients will return for visits every 2-4 weeks to have the following performed: vital signs and targeted physical will be taken; concomitant medications and any adverse events will be assessed.
Safety, laboratory, and clinical assessments, as well as questionnaires will be performed at specified clinic visits. A serum pregnancy test will be performed at Screening and urine pregnancy tests will be performed at Baseline and every 2-4 weeks prior to administration of the study drug, if applicable. Clinical photographs of the skin lesions will be taken at each visit.
Skin biopsies will be performed on all patients at Baseline and Week 24 or Early Termination visit. At Baseline, biopsies will be obtained from involved and uninvolved areas of a CTCL lesion. At Week 24 or Early Termination visit, the biopsy will be performed in the vicinity of the involved area biopsied at Baseline. An optional biopsy will be performed at Week 12, within the same area that was biopsied at Baseline.
At Baseline, serum will be obtained for DNA (1 PaxGene), RNA (2 PaxGene), and proteomic analysis (2 tubes serum). Studies of RNA and proteomic analysis will further be performed at Weeks 12, 24 and 48/early termination.
- Conditions
- CTCL, Mycosis Fungoides, Sezary Syndrome
- Being tested
- Ritlecitinib
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitlecitinibDrug
200 mg QD for 8 weeks followed by 100 mg for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Open-Label Ritlecitinib Receives: Drug: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Severity Weighted Assessment Tool (mSWAT)
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.
Measured: Baseline and Week 24
Secondary outcomes (12)
Change in Modified Severity Weighted Assessment Tool (mSWAT)
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.
Measured: Baseline and at each visit from week 2 to week 48 / EOS except for week 24
Treatment Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events
Measured: up to Week 48/EOS
Number of Serious Adverse Events
Number of serious adverse events (SAE) leading to discontinuation
Measured: up to Week 48/EOS
Number of Adverse Events
Number of Adverse events (AE) leading to discontinuation
Measured: up to Week 48/EOS
Number of clinically significant abnormalities in vital signs
Number of clinically significant abnormalities in any vital signs
Measured: up to Week 48/EOS
Number of clinically significant abnormalities in clinical laboratory values
Number of clinically significant abnormalities in any clinical laboratory values
Measured: up to Week 48/EOS
Change in Percentage of patients achieving 50% or greater improvement in mSWAT score
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.
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Change in Global Response Score
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
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of health-related quality of life (Skindex-29)
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.
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of health-related quality of life (FACT-G)
Absolute change of health-related quality of life (FACT-G - questionnaire regarding Physical/Social/Family well being) from Baseline up to Week 48.
The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). Full scale scored from 0-108. The higher the score, the better the quality of life.
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of IPQ-R (Illness perception questionnaire)
Absolute change of IPQ-R (Illness perception questionnaire) from Baseline up to Week 48.
The IPQ-R an 70-item instrument developed to provide a quantitative measurement of the components of illness representations. It is divided into three sections: identity subscale (14 symptoms scored as 1-yes or 0-no, subscale from 0-14), views about illness (38 questions scored between 5-strongly agree to 1-strongly disagree, subscale from 38-190) and a third section regarding views on possible causes (18 causes scored between 5-strongly agree to 1-strongly disagree, subscale from 18-90).
Full scale from 56-294. High scores on the identity and views of illness sections represent strongly held beliefs about the number of symptoms attributed, the negative consequences, and the chronicity and cyclical nature of the illness. High scores in the section regarding causes represent positive beliefs about controllability and a personal understanding of the illness.
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Percentage change of pruritus according to visual analogue scale (VAS)
Percentage change of pruritus according to visual analogue scale (VAS). Line graph to collect information about general itch level as well as worst itch level in the past 24 hours on a scale of 0 to 10, with higher score indicating more itch from baseline up to week 48.
Measured: Baseline and at each visit from week 2 to week 48 / EOS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 May 2023
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Why it stopped: No significant improvement in disease as graded by our assessments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTCLStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Patrick Brunner, Icahn School of Medicine at Mount Sinai
- Investigators
- Patrick Brunner, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879458
- Sponsor's protocol ID
- GCO 23-0107
- Status last verified
- Jul 2025
- First submitted
- 18 May 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be analyzed and published as aggregate data
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Open-label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib (PF-06651600) in Patients With Cutaneous T Cell Lymphomas
- ClinicalTrials.gov ID
- NCT05879458
- Acronym / sponsor ID
- GCO 23-0107
- Conditions
- CTCL, Mycosis Fungoides, Sezary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No significant improvement in disease as graded by our assessments.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 17 May 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the effectiveness and safety of Ritlecitinib in skin and blood in persons with Cutaneous T-Cell Lymphoma (CTCL). CTCL is a rare type of cancer that starts in the white blood cells and eventually can result in rashes or tumors in the skin. This study includes a 24 week Treatment Period and a 24 week Follow-up Period. This study will involve physical examinations, visual assessments, laboratory tests, PET-CT scans, electrocardiograms, photographs of your skin, skin biopsies, and hearing tests.
Detailed description
After providing informed consent, patients will be assessed for study eligibility at the Screening visit (day -28 to day -1) which includes: assessment of inclusion/exclusion criteria; targeted physical examination (including vital signs); mSWAT scoring and disease staging; electrocardiogram (ECG); review of medical history and concomitant medications as well as prior medications/treatments; and serum pregnancy test (if applicable). Laboratory tests will be performed for Complete Blood Count (CBC) with differentials (basophils, eosinophils, lymphocytes, monocytes, neutrophils), serum chemistry including albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, creatine kinase, potassium, sodium, total bilirubin, LDH, viral surveillance panel (EBV, CMV, HSV1, HSV2, and VZV), as well as hepatitis B surface antigen (HBsAg), HBcAb, hepatitis C antibody, and undergo testing for human immunodeficiency virus (HIV). Urinalysis will be performed. Patients will also undergo tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) testing. Patients will also undergo flow cytometric analyses and TCR rearrangement studies of peripheral blood to monitor potential CTCL blood involvement. CT scans with PET (positron emission tomography) scans will be performed within 4 weeks before baseline to help establish or confirm peripheral lymph node size and assign TNM classification, or at any time if internal involvement is suspected by the investigator.
Patients who meet eligibility criteria (meeting all inclusion and no exclusion criteria) will undergo Baseline / Day 0 assessments. These assessments include vital signs and targeted physical examination, mSWAT scoring, clinical disease staging, questionnaires, clinical photography, urine pregnancy test (if applicable), and blood collection for chemistry, hematology, mechanistic studies, baseline for drug levels, blood DNA analysis, blood RNA analysis, and blood proteomic analysis. Two skin biopsies will be obtained (one from an involved area and one from an adjacent uninvolved area). Concomitant medications and any adverse events will be assessed.
Patients will then receive the first oral dose (200mg) of ritlecitinib. Patients will continue to receive the study drug QD through Week 24.
Patients will return for visits every 2-4 weeks to have the following performed: vital signs and targeted physical will be taken; concomitant medications and any adverse events will be assessed.
Safety, laboratory, and clinical assessments, as well as questionnaires will be performed at specified clinic visits. A serum pregnancy test will be performed at Screening and urine pregnancy tests will be performed at Baseline and every 2-4 weeks prior to administration of the study drug, if applicable. Clinical photographs of the skin lesions will be taken at each visit.
Skin biopsies will be performed on all patients at Baseline and Week 24 or Early Termination visit. At Baseline, biopsies will be obtained from involved and uninvolved areas of a CTCL lesion. At Week 24 or Early Termination visit, the biopsy will be performed in the vicinity of the involved area biopsied at Baseline. An optional biopsy will be performed at Week 12, within the same area that was biopsied at Baseline.
At Baseline, serum will be obtained for DNA (1 PaxGene), RNA (2 PaxGene), and proteomic analysis (2 tubes serum). Studies of RNA and proteomic analysis will further be performed at Weeks 12, 24 and 48/early termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: RitlecitinibOpen-Label Ritlecitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at time of enrollment
- CTCL >10% BSA involvement (stage IB-IVA by ISCL/EORTC staging criteria), previously confirmed by histopathology
- CTCL subtypes eligible for this study include Mycosis fungoides and its subtypes, as well as Sézary Syndrome.
- Failure of at least 2 skin-directed (ISCL/EORTC stage IB-IIA, i.e. early stage disease) or systemic treatments (ISCL/EORTC stage IIB-IVA, i.e. late stage disease) due to progression or toxicity as assessed by the prescribing physician or by the principal investigator, or insufficient response to established skin-directed or systemic treatments.
- Adequate hematological (Hb>9.0g/dl, absolute neutrophil count >1200/ul, platelets >75x10^9/L, absolute [non-malignant] lymphocyte count >800/ul), hepatic (AST and ALT <2x times upper limit of normal), and renal function (eGFR [CKD-EPI creatinine equation >50mL/min/1.73m2)
Key exclusion criteria (26 listed)
- History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
- Immunosuppressed by previous (within 4 weeks) or current systemic cytotoxic therapies, as evidenced by recurrent skin or systemic infections
- Pregnant or breast-feeding women
- Unwillingness or inability to use a contraception method during the time of participation in the trial.
- Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class III or IV; unstable angina pectoris within 6 months of study enrollment; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritlecitinib200 mg QD for 8 weeks followed by 100 mg for 16 weeks | Drug | Treatment Arm |
Primary outcome
Change in Modified Severity Weighted Assessment Tool (mSWAT)
Time frame: 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.
12 secondary outcomes
Change in Modified Severity Weighted Assessment Tool (mSWAT)
Time frame: Baseline and at each visit from week 2 to week 48 / EOS except for week 24
Treatment Emergent Adverse Events
Time frame: up to Week 48/EOS
Number of Serious Adverse Events
Time frame: up to Week 48/EOS
Number of Adverse Events
Time frame: up to Week 48/EOS
Number of clinically significant abnormalities in vital signs
Time frame: up to Week 48/EOS
Number of clinically significant abnormalities in clinical laboratory values
Time frame: up to Week 48/EOS
Change in Percentage of patients achieving 50% or greater improvement in mSWAT score
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Change in Global Response Score
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of health-related quality of life (Skindex-29)
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of health-related quality of life (FACT-G)
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Absolute change of IPQ-R (Illness perception questionnaire)
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Percentage change of pruritus according to visual analogue scale (VAS)
Time frame: Baseline and at each visit from week 2 to week 48 / EOS
Results and safety
The study was stopped early (reason given: No significant improvement in disease as graded by our assessments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. Results will be analyzed and published as aggregate data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Brunner, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritlecitinib in people with CTCL and Mycosis Fungoides, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No significant improvement in disease as graded by our assessments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Severity Weighted Assessment Tool (mSWAT) (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.