TerminatedNCT03713320SOLARUpdated Apr 8, 2022Results posted

SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

A Phase 2 interventional study of Cobomarsen and Vorinostat in Cutaneous T-Cell Lymphoma/Mycosis Fungoides, sponsored by miRagen Therapeutics, Inc.. Terminated at 43 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by miRagen Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy.

Phase: Phase 2
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

Read the detailed description

Study Design:

Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis.

Conditions studied

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

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Keywords

SOLAR
Cutaneous T-cell Lymphoma
CTCL
Mycosis Fungoides
Lymphoma
Lymphoma, T-cell
Lymphoma, T-cell, cutaneous
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms
MicroRNAs
Vorinostat
Histone Deacetylase Inhibitors

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Biopsy-proven CTCL, MF subtype
Clinical stage IB, II, or III, with staging based on screening assessments
Minimum mSWAT score of 10 at screening
Receipt of at least one prior therapy for CTCL

Key Exclusion Criteria:

Previous enrollment in a cobomarsen study
Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor
Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening
Evidence of large cell transformation
Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant
Visceral involvement related to MF at screening

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Cobomarsen
Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter
Drug: Cobomarsen
Active comparator
Vorinostat
Vorinostat will be administered orally at a dose of 400 mg (four 100-mg capsules) once daily with food, at approximately the same time each day.
Drug: Vorinostat

Interventions

DrugCobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period
Also known as: MRG-106
DrugVorinostat
Daily doses of vorinostat throughout study treatment period

What researchers measure

Primary outcomes

Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
Time frame: Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Secondary outcomes

Progression-free Survival (PFS)
Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Complete Response Rate
Percentage of subjects with a complete response in the skin based on mSWAT
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Progression
Time from date of randomization until the earliest date of confirmed progression
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Maximal Effect in mSWAT
Time to greatest improvement in mSWAT score
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days
Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose
Time frame: 28 days after first dose
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months
Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose
Time frame: 4 months after first dose
Time to ≥ 50% Improvement in mSWAT
Time from date of randomization until ≥ 50% improvement in mSWAT score
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Duration of Response in Skin
Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Pruritus Medication Utilization
Change from baseline in number of pruritus medications taken per subject
Time frame: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Other outcomes

Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose
Peak plasma concentration (Cmax) of cobomarsen after first dose
Time frame: 1, 1.92, 6, 24 and 48 hours post-dose after the first dose
Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5
Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5)
Time frame: 1, 1.92 and 6 hours post-dose after the Week 5 dose
Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5
Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose
Time frame: 1, 1.92 and 6 hours post-dose after the Week 5 dose
Number of Participants With Anti-drug Antibody Generation
Number of participants who develop antibodies to cobomarsen during treatment
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Results

Posted Apr 8, 2022

Limitations and caveats

The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy. Because the study was terminated early, enrollment was ended at 37 participants instead of the initially planned 126 participants, and a planned interim analysis based on these 37 participants was the only analysis performed for the study. The study duration was also shortened from an estimated 36 months to 20 months overall.

Participant flow

Randomized Period

Participant flow — Randomized Period
Milestone	Cobomarsen (Randomized)	Vorinostat (Randomized)
Started	19	18
Completed	4	8
Not completed	15	10
Withdrew: Adverse event	1	5
Withdrew: Physician decision	1	1
Withdrew: Withdrawal by subject	4	0
Withdrew: Participant decision	3	1
Withdrew: Study terminated by sponsor	6	3

Cobomarsen Crossover Period

Participant flow — Cobomarsen Crossover Period
Milestone	Cobomarsen (Randomized)	Vorinostat (Randomized)	Cobomarsen (Crossover)
Started	0	0	7
Completed	0	0	0
Not completed	0	0	7
Withdrew: Physician decision	0	0	2
Withdrew: Sponsor decision to terminate trial	0	0	5

Outcome measures

PrimaryPercentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)

ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

Time frame:: Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Number · Percentage of participants

Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
Percentage of participants	Cobomarsen (Randomized)	Vorinostat (Randomized)
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)	15.8	16.7

Statistical analysis

Cobomarsen (Randomized) vs Vorinostat (Randomized) · Cochran-Mantel-Haenszel · p = .9539

SecondaryProgression-free Survival (PFS)

Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.

Time frame:: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Median · months

Progression-free Survival (PFS)
months	Cobomarsen (Randomized)	Vorinostat (Randomized)
Progression-free Survival (PFS)	NA (9.26 to NA)	6.01 (2.89 to 8.90)

Statistical analysis

Cobomarsen (Randomized) vs Vorinostat (Randomized) · Regression, Cox · p = 0.011

SecondaryComplete Response Rate

Percentage of subjects with a complete response in the skin based on mSWAT

Time frame:: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Number · Percentage of participants

Complete Response Rate
Percentage of participants	Cobomarsen (Randomized)	Vorinostat (Randomized)
Complete Response Rate	0	5.6

SecondaryTime to Progression

Time from date of randomization until the earliest date of confirmed progression

Time frame:: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Mean · Months

Time to Progression
Months	Cobomarsen (Randomized)	Vorinostat (Randomized)
Time to Progression	NA (9.26 to NA)	6.01 (2.89 to 8.90)

SecondaryTime to Maximal Effect in mSWAT

Time to greatest improvement in mSWAT score

Time frame:: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Mean · Months

Time to Maximal Effect in mSWAT
Months	Cobomarsen (Randomized)	Vorinostat (Randomized)
Time to Maximal Effect in mSWAT	4.5 ± 3.7	3.0 ± 2.7

SecondaryObjective Response Rate in the Skin of at Least 28-days Duration (ORR1)

Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration

Time frame:: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Number · percentage of participants

Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
percentage of participants	Cobomarsen (Randomized)	Vorinostat (Randomized)
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)	31.6	33.3

SecondaryPercentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose

Time frame:: 28 days after first dose
Reported as:: Number · percentage of participants

Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days
percentage of participants	Cobomarsen (Randomized)	Vorinostat (Randomized)
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days	5.3	11.1

SecondaryPercentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose

Time frame:: 4 months after first dose
Reported as:: Number · percentage of participants

Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months
percentage of participants	Cobomarsen (Randomized)	Vorinostat (Randomized)
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months	21.1	22.2

SecondaryTime to ≥ 50% Improvement in mSWAT

Time from date of randomization until ≥ 50% improvement in mSWAT score

Time frame:: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Mean · Months

Time to ≥ 50% Improvement in mSWAT
Months	Cobomarsen (Randomized)	Vorinostat (Randomized)
Time to ≥ 50% Improvement in mSWAT	3.7 ± 2.7	2.7 ± 1.8

SecondaryDuration of Response in Skin

Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)

Time frame:: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Median · Months

Duration of Response in Skin
Months	Cobomarsen (Randomized)	Vorinostat (Randomized)
Duration of Response in Skin	NA (NA to NA)	7.85 (6.60 to NA)

SecondaryPruritus Medication Utilization

Change from baseline in number of pruritus medications taken per subject

Time frame:: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Reported as:: Mean · Number of pruritus medications

Pruritus Medication Utilization
Number of pruritus medications	Cobomarsen (Randomized)	Vorinostat (Randomized)
Pruritus Medication Utilization	-1 ± 2.39	-0.9 ± 1.35

Other pre-specifiedPeak Plasma Concentration (Cmax) of Cobomarsen - First Dose

Peak plasma concentration (Cmax) of cobomarsen after first dose

Time frame:: 1, 1.92, 6, 24 and 48 hours post-dose after the first dose
Reported as:: Mean · µg/mL

Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose
µg/mL	Cobomarsen (Randomized)
Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose	10.5 ± 7.17

Other pre-specifiedPeak Plasma Concentration (Cmax) of Cobomarsen - Week 5

Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5)

Time frame:: 1, 1.92 and 6 hours post-dose after the Week 5 dose
Reported as:: Mean · µg/mL

Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5
µg/mL	Cobomarsen (Randomized)
Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5	9.34 ± 3.24

Other pre-specifiedArea Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5

Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose

Time frame:: 1, 1.92 and 6 hours post-dose after the Week 5 dose
Reported as:: Mean · µg*hr/mL

Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5
µg*hr/mL	Cobomarsen (Randomized)
Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5	25.5 ± 6.27

Other pre-specifiedNumber of Participants With Anti-drug Antibody Generation

Number of participants who develop antibodies to cobomarsen during treatment

Time frame:: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

No measurements were reported for this outcome.

Adverse events

Collected over All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cobomarsen (Randomized)	0/19 (0%)	2/19 (10.5%)	18/19 (94.7%)
Vorinostat (Randomized)	0/18 (0%)	1/18 (5.6%)	18/18 (100%)
Cobomarsen (Crossover)	0/7 (0%)	0/7 (0%)	5/7 (71.4%)

Most frequent serious events

Most frequent serious events
Event	Cobomarsen (Randomized)	Vorinostat (Randomized)	Cobomarsen (Crossover)
Infusion related reactionInjury, poisoning and procedural complications	0/19	1/18	0/7
Skin infectionInfections and infestations	1/19	0/18	0/7
Superinfection of Skin LesionsInfections and infestations	1/19	0/18	0/7

Most frequent other events

Showing 10 of 144

Most frequent other events
Event	Cobomarsen (Randomized)	Vorinostat (Randomized)	Cobomarsen (Crossover)
DiarrhoeaGastrointestinal disorders	7/19	8/18	1/7
NauseaGastrointestinal disorders	8/19	6/18	0/7
FatigueGeneral disorders	7/19	6/18	2/7
PruritusSkin and subcutaneous tissue disorders	7/19	4/18	0/7
Muscle spasmsMusculoskeletal and connective tissue disorders	2/19	6/18	0/7
HypertensionVascular disorders	3/19	5/18	2/7
AlopeciaSkin and subcutaneous tissue disorders	1/19	5/18	0/7
HeadacheNervous system disorders	5/19	1/18	0/7
Skin infectionSkin and subcutaneous tissue disorders	5/19	0/18	0/7
Decreased appetiteMetabolism and nutrition disorders	1/19	4/18	0/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Cobomarsen	Vorinostat	Total
<=18 years	0	0	0
Between 18 and 65 years	13	14	27
>=65 years	6	4	10

Sex: Female, Male
Sex: Female, Male(Participants)	Cobomarsen	Vorinostat	Total
Female	9	7	16
Male	10	11	21

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cobomarsen	Vorinostat	Total
Hispanic or Latino	4	1	5
Not Hispanic or Latino	14	14	28
Unknown or Not Reported	1	3	4

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cobomarsen	Vorinostat	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	17	13	30
More than one race	0	0	0
Unknown or Not Reported	2	3	5

Region of Enrollment
Region of Enrollment(participants)	Cobomarsen	Vorinostat	Total
Canada	1	0	1
Belgium	2	3	5
United States	9	8	17
Italy	0	1	1
United Kingdom	4	2	6
France	1	3	4
Spain	2	1	3

Skin tumor at screening
Skin tumor at screening(Participants)	Cobomarsen	Vorinostat	Total
Count of participants	6	4	10

No skin tumor at screening
No skin tumor at screening(Participants)	Cobomarsen	Vorinostat	Total
Count of participants	13	14	27

Lactate dehydrogenase (LDH) is greater than upper limit normal (ULN) at diagnosis
Lactate dehydrogenase (LDH) is greater than upper limit normal (ULN) at diagnosis(Participants)	Cobomarsen	Vorinostat	Total
Count of participants	4	2	6

2 further baseline measures are reported on the registry.

Study locations

43 sites

The University of Alabama at Birmingham
Birmingham, Alabama 35233, United States
Mayo Clinic
Phoenix, Arizona 85054, United States
City of Hope
Duarte, California 91010, United States
UCLA
Los Angeles, California 90404, United States
Chao Family Comprehensive Cancer Center at University of California, Irvine
Orange, California 92868, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510, United States
Mayo Clinic
Jacksonville, Florida 32224, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612, United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Washington University School of Medicine
Saint Louis, Missouri 63108, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Rochester Skin Lymphoma Medical Group
Fairport, New York 14450, United States
Columbia University Medical Center
New York, New York 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031, United States
University of Washington
Seattle, Washington 98109, United States
Concord Repatriation General Hospital
Concord, New South Wales 2139, Australia
Westmead Hospital
Westmead, New South Wales NSW 2145, Australia
Linear Clinical Research
Nedlands, 6009, Australia
University Clinic UZ Leuven
Leuven, B3000, Belgium
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2, Canada
Jewish General Hospital
Montréal, Quebec H3T 1E2, Canada
Hôpital Saint André, CHU de Bordeaux
Bordeaux, 33000, France
Hôpital Saint-Louis
Paris, 75010, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310, France
Hôpital Robert Dubré, CHU de Reims
Reims, 51100, France
Centre Hospitalier Universitaire de Rouen
Rouen, 76031, France
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano, 20122, Italy
AOU Citta dell Salute e della Scienza di Torino
Torino, 10126, Italy
Vall d'Hebron Institute of Oncology
Barcelona, 08035, Spain
Fundación Jiménez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Consorcio Hospital General Universitario Valencia
Valencia, 46014, Spain
University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust, Cancer Center
London, SE1 9RT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom

References and documents

Publications

Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7. PubMed 33085815 ↗
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3. PubMed 32632956 ↗

Study documents

Protocol and statistical analysis plan · Feb 10, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03713320
Lead sponsor: miRagen Therapeutics, Inc.
Responsible party: Sponsor
First posted: Oct 19, 2018
Start date: Apr 2, 2019
Primary completion: Oct 12, 2020
Completion: Dec 1, 2020
Results posted: Apr 8, 2022
Last update: Apr 8, 2022

Study contacts

Diana M. Escolar, MD, FAAN

study director · miRagen Therapeutics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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