Chronic Hand EczemaPhase 2DUPECZEMAINNCT03861455
Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids
A Phase 2 study testing Dupilumab in people with Chronic Hand Eczema, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Jul 2019to 20 Dec 2023
- 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
- Patients affiliated to a social insurance protection regimen.
- Patients with moderate to severe chronic (>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4).
- Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 [indicating clear] to 2 [indicating mild]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids.
- Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires.
- Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit.
- Patients who agree to sign the written informed consent.
Who cannot join
- Hypersensitivity to dupilumab or to any of its ingredients
- Patients under adult autonomy protection system
- Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect.
- Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline.
- Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit.
- Treatment with an investigational drug within 8 weeks (or 5 half-lives) of baseline.
Show all 12Show fewer
- Active chronic infection requiring the use of a systemic antibiotic within 2 weeks before study start.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit.
- Patients with known helminth infections.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method
Trial locations and contacts
4 sites in 1 country.
France4 sites
Saint André Hospital
Bordeaux, 30000
Hôpital Saint Eloi
Montpellier, 34000
CHU Lyon-Sud Département d'allergologie et d'immunologie clinique
Pierre-Bénite, 69495
Larrey Hospital
Toulouse, 31059
About this study
Official title: DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids
Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
Read the detailed description
Chronic hand eczema is a frequent chronic inflammatory skin disease which may have significant physical, psychological and social impact on daily activities, emotional and social life as well as work. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
- Conditions
- Chronic Hand Eczema
- Being tested
- Dupilumab, placebo
- Keywords
- Chronic Hand Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
placeboDrug
patient receive placebo
| Study group | Role | What they receive |
|---|---|---|
| dupilumab group | Experimental | patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 Receives: Drug: Dupilumab |
| placebo group | Placebo comparator | patient receive placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity score mTLSS (modified Total Lesion Symptom Score)
The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score) The mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain.
The seven individual CHE symptoms; (erythema, scaling, lichenification or hyperkeratosis, vesiculation, edema, fissures, and pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease).
Measured: Week 16
Secondary outcomes (14)
Evolution of pruritus
Evolution of pruritus associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale (VAE) from 0 (no itching) to 100 (intense itching).
Measured: Week 16
Evolution of pain
Evolution of pain associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale from 0 (no pain) to 100 (intense skin pain).
Measured: Week 16
Improvement of quality of life
Improvement of quality of life at week 16 since baseline measured by DLQI (Dermatology Life Quality Index) composed of 10 questions (4 possibilities per questions: very much, a lot, a little, not at all).
Measured: Week 16
Improvement of quality of life by EQ-5D-5L
Improvement of quality of life at week 16 since baseline measured by EQ-5D-5L. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his or her current health state using a 0 to 100 mm VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his or her health state by ticking (or placing a cross) in the box associated with the most appropriate statement in each of the 5 dimensions. The VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labeled "best imaginable health state" and "worst imaginable health state." This information can be used as a quantitative measure of health outcome.
Measured: Week 16
evolution of sleep loss
Evolution of sleep loss associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale from 0 (no sleep disorder) to 100 (severe sleep loss).
Measured: Week 16
IGA - Clearance
Clearance or almost clearance of hand eczema at week 16 as defined by an Investigator's global assessment (IGA) of 0 or 1, on a 5 range scale ( from 0 = Clear to 4 = severe disease)
Measured: Week 16
PaGa - Clearance
Clearance or almost clearance of hand eczema at week 16 as assessed by the Patient's global assessment (PaGa) of 0 or 1. The PGA is a single-item question asking the patient how they would rate their overall symptoms. The 5 categories of responses range from "no symptoms"(0) to "severe."(4)
Measured: Week 16
Improvement of work productivity
Improvement of work productivity at week 16 since baseline as assessed by the WPAI questionnaire (Work Productivity and Activity Impairment). The WPAI consists of 6 items grouped into 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. Scores are calculated as impairment percentages, with higher scores indicating greater impairment and less productivity.
Measured: Week 16
Evolution of the Eczema Area and Severity Index (EASI)
Evolution of the Eczema Area and Severity Index at week 16 since baseline in patients who have eczema on other parts of the body than the hands. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome.
Measured: Week 16
Incidence of Treatment-Emergent Adverse Event
The safety throughout the course of the study (at 20 weeks since baseline) by monitoring adverse events, serious adverse events, injection site reactions
Measured: Week 16
evolution of laboratory parameters - full blood count
The evolution of laboratory parameters (full blood count) at week 16 since baseline
Measured: Week 16
evolution of laboratory parameters - transaminases
The evolution of laboratory parameters (transaminase) at week 16 since baseline
Measured: Week 16
evolution of laboratory parameters - total immunoglobulin E
The evolution of laboratory parameters (total immunoglobulin E) at week 16 since baseline
Measured: Week 16
evolution of laboratory parameters - specific immunoglobulin E
The evolution of laboratory parameters (specific immunoglobulin E) at week 16 since baseline
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start15 Jul 2019
- Primary completion9 Nov 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Tauber, Study director, Lyon Sud Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861455
- Sponsor's protocol ID
- RC31/18/0269
- Other IDs
- 2018-002830-19, 2018
- Acronym
- DUPECZEMAIN
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. French.
PubMed 24953620Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, De Pita O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.
PubMed 24102212Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.
PubMed 25607554Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.
PubMed 28478972Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letule V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.
PubMed 25244099
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids
- ClinicalTrials.gov ID
- NCT03861455
- Acronym / sponsor ID
- DUPECZEMAIN / RC31/18/0269
- Conditions
- Chronic Hand Eczema
- Keywords
- Chronic Hand Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 4 Mar 2019 (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.
Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
Detailed description
Chronic hand eczema is a frequent chronic inflammatory skin disease which may have significant physical, psychological and social impact on daily activities, emotional and social life as well as work. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 or placebo.
| Arm | Type | Receives |
|---|---|---|
| dupilumab group | Experimental | Drug: Dupilumabpatient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 |
| placebo group | Placebo comparator | Drug: placebopatient receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients affiliated to a social insurance protection regimen.
- Patients with moderate to severe chronic (>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4).
- Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 [indicating clear] to 2 [indicating mild]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids.
- Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires.
- Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit.
Key exclusion criteria (12 listed)
- Hypersensitivity to dupilumab or to any of its ingredients
- Patients under adult autonomy protection system
- Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect.
- Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline.
- Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit.
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 |
|---|---|---|
| Dupilumabpatient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 | Drug | dupilumab group |
| placebopatient receive placebo | Drug | placebo group |
Primary outcome
severity score mTLSS (modified Total Lesion Symptom Score)
Time frame: Week 16
The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score) The mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain. The seven individual CHE symptoms; (erythema, scaling, lichenification or hyperkeratosis, vesiculation, edema, fissures, and pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease).
14 secondary outcomes
Evolution of pruritus
Time frame: Week 16
Evolution of pain
Time frame: Week 16
Improvement of quality of life
Time frame: Week 16
Improvement of quality of life by EQ-5D-5L
Time frame: Week 16
evolution of sleep loss
Time frame: Week 16
IGA - Clearance
Time frame: Week 16
PaGa - Clearance
Time frame: Week 16
Improvement of work productivity
Time frame: Week 16
Evolution of the Eczema Area and Severity Index (EASI)
Time frame: Week 16
Incidence of Treatment-Emergent Adverse Event
Time frame: Week 16
evolution of laboratory parameters - full blood count
Time frame: Week 16
evolution of laboratory parameters - transaminases
Time frame: Week 16
evolution of laboratory parameters - total immunoglobulin E
Time frame: Week 16
evolution of laboratory parameters - specific immunoglobulin E
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 24953620Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. French.
- Background: PubMed 24102212Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, De Pita O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.
- Background: PubMed 25607554Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.
- Background: PubMed 28478972Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.
- Background: PubMed 25244099Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letule V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.
- Individual participant dataSharing planned: No
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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.
Marie Tauber study director
Lyon Sud Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Chronic Hand Eczema, run by University Hospital, Toulouse at 4 sites in France.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
severity score mTLSS (modified Total Lesion Symptom Score) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861455, which also lists 5 linked publications.
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 3 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.