A Phase 2 interventional study of resminostat and Placebo in Mycosis Fungoides, Sezary Syndrome and Lymphoma, T-Cell, Cutaneous, sponsored by 4SC AG. Completed at 54 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by 4SC AG · Phase 2, Interventional, and Treatment
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Among 23 studies in Mycosis Fungoides with a site in Germany — none open to participants now, none under way, none of them phase 3. Mycosis Fungoides · Germany.
Among the 23 studies in Mycosis Fungoides with a site in Germany, this one is the 2nd largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2016, is one of 8 in phase 2, and was the 22nd registered.
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
Browse Mycosis Fungoides studies →None of the 23 studies in Mycosis Fungoides with a site in Germany is open now. The open studies under Mycosis Fungoides, anywhere →
Of the 30 Mycosis Fungoides studies recruiting now, 25 (83%) set no upper age limit and 1 (3%) stops at 75 or younger; 2 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 5 · Phase 4 2
First in 1994; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 201 is above the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.
Median enrollment 93 across the 21 interventional studies, 304 across the 1 observational. Of the 22 that completed or were terminated, 2 (9%) have results posted.
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10 of 23 have an industry lead sponsor. The 10 most frequent:
4SC AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
4SC AG has 2 studies filed under Mycosis Fungoides — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Mycosis Fungoides with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: resminostat
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: Placebo
Also known as: 4SC-201
PFS (Progression-free survival)
The primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) with previous systemic therapy.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 32 months
TTSW (Time to symptom worsening): pruritus
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
Time frame: From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale
TTP (Time to progression)
Compare time to progression (TTP) in patients when treated with resminostat vs placebo
Time frame: From date of randomization until the date of first documented progression, up to approximately 32 months
TTNT (Time to next treatment)
Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo
Time frame: From date of randomisation to first date that new treatment is received, up to approximately 44 months.
PFS2, PFS3 (Progression-free survival 2, 3)
Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)
Time frame: From date of start of subsequent treatment to date of progression or death due to any cause in the absence of documented PD whilst receiving second and third line therapy, respectively, up to approximately 44 months
ORR (Overall response rate)
Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo
Time frame: Percent of patients within each treatment Arm that achieve confirmed CR or PR relative to the number of patients belonging to the analysis population of interest, up to approximately 32 months.
DOR (Duration of response)
Compare duration of response (DOR) in patients when treated with resminostat vs placebo
Time frame: From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
OS (Overall survival)
Compare overall survival (OS) in patients when treated with resminostat vs placebo
Time frame: From the day of randomisation to death from any cause, up to approximately 44 months.
Incidence of treatment-related AEs and SAEs (Safety and tolerability)
Assess the safety and tolerability of resminostat
Time frame: Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
HrQoL (Health related quality of life)
Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo
Time frame: Every 28 days, up to approximately 32 months
Maximum Plasma Concentration [Cmax]
Assess the maximum plasma concentration \[Cmax\] of resminostat and metabolites
Time frame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Area Under the Curve [AUC]
Assess the Area Under the Curve \[AUC\] of resminostat and metabolites
Time frame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Plan to share: No
Ran from Nov 2016 to primary completion in Mar 2023, 76 months.
Of 42 phase 2 interventional studies under Mycosis Fungoides, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 111. This study's 76 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Resminostat
4SC AG