Scleroderma, SystemicPhase 2/3DesiReSNCT04274257
A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis
A Phase 2/3 study testing Double-Blind Rituximab in people with Scleroderma, Systemic and Skin Sclerosis, run by Tokyo University at 4 sites in Japan.
Trial summary
This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Scleroderma, Systemic, Skin Sclerosis, Lung Fibrosis
- What is being tested?
- Double-Blind Rituximab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesJapan
- Study dates
- 4 Dec 2017to 5 Nov 2019
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill the diagnostic criteria for systemic sclerosis defined in the 2016 edition of the Clinical Practice Guidelines for Systemic Sclerosis and have an mRTSS of 2 (moderate) or higher for skin sclerosis
- Aged 20 or older and younger than 80 at the time of consent
- Have an expected survival of at least 6 months (and expected to allow 6 months of observation)
- Fulfill the following criteria related to concomitant medications/therapies:
- Not received corticosteroids equivalent to more than 10 mg/day of prednisolone within 2 weeks before the start of study treatment; and
- Not received antifibrotic agents (like nintedanib, pirfenidone, tocilizumab), other investigational products, immunosuppressants (cyclophosphamide, mycophenolate mofetil, ciclosporin, tacrolimus, azathioprine, and mizoribine), high-dose intravenous immunoglobulin, or imatinib 4 weeks prior to the start of study treatment.
- Provided written consent to participate in the study
Who cannot join
- Present with pulmonary hypertension* associated with systemic sclerosis
- : The patient will undergo echocardiography during the pre-treatment observation period to exclude pulmonary hypertension. The patient will be required to undergo examination by an expert (eg, at the Department of Cardiovascular Medicine) if systolic pulmonary artery pressure exceeds 35 mmHg.
- Have serious complications (eg, renal crisis) associated with systemic sclerosis (excluding interstitial pneumonia**)
- : Patients with interstitial pneumonia will be excluded if the criterion 3) below is met.
- Have only poor respiratory reserve (%VC or %DLco, both calculated using the "estimation equation more suitable for Japanese," is less than 60% or 40%, respectively)
- Known to have HIV antibodies
Show all 21Show fewer
- Have a positive result for any of the following: HBs antigen, HBs antibody, HBc antibody, and HCV antibody (this criterion does not apply to a positive test for hepatitis B clearly attributable to hepatitis vaccination)
- Have serious bacterial/fungal infections
- Have a serious liver disease (AST [GOT] or ALT[GPT] of ≥ 300 IU)
- Have a serious renal disease (serum creatinine ≥ 2.0 mg/dL)
- Have severe heart disease
- Have active tuberculosis
- Have any known malignancy or a history of malignancy within the past 5 years
- Have a history of serious infections
- Have a history of serious hypersensitivity or anaphylactic reactions to any component of rituximab or to mouse proteins
- Pregnant, postpartum, and lactating women
- Refuse to practice contraception from the time of consent to at least 12 months after study completion
- Have any disease or physical/psychiatric conditions that make study participation difficult/inappropriate
- Received other investigational products within 12 weeks prior to the study treatment or are participating in other clinical research/studies
- Smoked within 12 weeks prior to the date of consent
- Is determined by the investigator (or sub-investigator) to be ineligible for the study for any other reason
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
University of Fukui Hospital
Fukui
Chukyo Hospital
Nagoya
The University of Tokyo Hospital
Tokyo, 113-8655
University of Tsukuba Hospital
Tsukuba
About this study
Official title: Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis
This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.
- Conditions
- Scleroderma, Systemic, Skin Sclerosis, Lung Fibrosis, Autoimmune Diseases, Collagen Diseases
- Being tested
- Double-Blind Placebo, Double-Blind Rituximab
- Medical subject headings
- Scleroderma, Systemic, Pulmonary Fibrosis, Autoimmune Diseases, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Blind PlaceboDrug
The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered.
Double-Blind RituximabDrug
The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind Placebo | Placebo comparator | Participants will receive double-blind matching placebo from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48. Receives: Drug: Double-Blind Placebo |
| Double-Blind Rituximab | Experimental | Participants will receive double-blind rituximab from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48. Receives: Drug: Double-Blind Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Rodnan Total Skin Thickness Score (mRTSS) during double-blind period
Absolute change from pre-treatment observation period in skin sclerosis at week 24 of treatment in the double-blind phase, assessed by mRTSS. mRTSS ranging from 0 (normal) to 3 (severe skin thickening) across 17 different body parts. The total score is the sum of the individual skin scores for all these sites, and ranges from 0 to 51 units.
Measured: From baseline to week 24
Secondary outcomes (40)
Change in percent FVC measured in respiratory function test
Measured: From baseline to week 24
Change in percent DLco measured in respiratory function test
Measured: From baseline to week 24
Change in TLC measured in respiratory function test
Measured: From baseline to week 24
Change in serum levels of KL-6
Measured: From baseline to week 24
Change in serum levels of SP-D
Measured: From baseline to week 24
Change in serum levels of SP-A
Measured: From baseline to week 24
Change in percentage of interstitial shadow in lungs by high-resolution computed tomography
Measured: From baseline to week 24
Change in skin thickness measured following biopsy specimen
Measured: From baseline to week 24
Change in HRQOL index measured using MOS 36 Item Short-Form Health Survey
Measured: From baseline to week 24
Change in QOL index of SSc patients, assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: From baseline to week 24
Change in serum antinuclear antibody titers
Measured: From baseline to week 24
Change in serum levels of anti-centromere antibodies
Measured: From baseline to week 24
Change in serum levels of anti-Scl-70 antibodies
Measured: From baseline to week 24
Change in serum levels of anti-RNA polymerase III antibodies
Measured: From baseline to week 24
Change in serum levels of anti-ssDNA antibodies
Measured: From baseline to week 24
Change in serum levels of anti-dsDNA antibodies
Measured: From baseline to week 24
Change in serum levels of anti-CL antibodies
Measured: From baseline to week 24
Change in serum levels of anti-β2-GP1 antibodies
Measured: From baseline to week 24
Change in serum levels of lupus anticoagulant
Measured: From baseline to week 24
Change in serum levels of anti-SS-A antibodies
Measured: From baseline to week 24
Change in serum levels of anti-SS-B antibodies
Measured: From baseline to week 24
Change in serum levels of anti-cANCA
Measured: From baseline to week 24
Change in serum levels of anti-p-ANCA
Measured: From baseline to week 24
Change in serum levels of anti-U1-RNP antibodies
Measured: From baseline to week 24
Change in serum levels of IgG
Measured: From baseline to week 24
Change in serum levels of IgM
Measured: From baseline to week 24
Change in serum levels of IgA
Measured: From baseline to week 24
Change in blood CD19+ B cell count
Measured: From baseline to week 24
Change in blood CD20+ B cell count
Measured: From baseline to week 24
Change in blood CD3+ T cell count
Measured: From baseline to week 24
Expression of human anti-rituximab antibodies
Measured: From baseline to week 24
Overall incidence, severity, causal relationship, and outcome of adverse events
Measured: From baseline to week 48
Incidence of rituximab infusion reactions
Measured: From baseline to week 48
PK profile of rituximab: Area under concentration-time curve from time 0 to final observation (AUC0-t)
Measured: From baseline to week 48
PK profile of rituximab: maximum serum concentration after dosing (Cmax)
Measured: From baseline to week 48
PK profile of rituximab: time to maximum concentration (tmax)
Measured: From baseline to week 48
PK profile of rituximab: terminal half-life (t1/2)
Measured: From baseline to week 48
PK profile of rituximab: mean residence time
Measured: From baseline to week 48
PK profile of rituximab: clearance
Measured: From baseline to week 48
PK profile of rituximab: volume of distribution
Measured: From baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start4 Dec 2017
- Primary completion9 May 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Zenyaku Kogyo Co., Ltd.
- Responsible party
- Principal investigator, Ayumi Yoshizaki, Tokyo University
- Investigators
- Ayumi Yoshizaki, MD, PhD, Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274257
- Sponsor's protocol ID
- 2017019-11DX
- Acronym
- DesiReS
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Okiyama N, Kodera M, Hasegawa M, Sato S. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): open-label extension of a double-blind, investigators-initiated, randomised, placebo-controlled trial. Lancet Rheumatol. 2022 Aug;4(8):e546-e555. doi: 10.1016/S2665-9913(22)00131-X. Epub 2022 Jun 28.
PubMed 38294008Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Asano Y, Okiyama N, Kodera M, Hasegawa M, Sato S. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): a double-blind, investigator-initiated, randomised, placebo-controlled trial. Lancet Rheumatol. 2021 Jul;3(7):e489-e497. doi: 10.1016/S2665-9913(21)00107-7. Epub 2021 May 26.
PubMed 38279402Ebata S, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Yoshihide A, Yoshizaki A, Sato S. Predictors of rituximab effect on modified Rodnan skin score in systemic sclerosis: a machine-learning analysis of the DesiReS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4364-4373. doi: 10.1093/rheumatology/keac023.
PubMed 35136981
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04274257
- Acronym / sponsor ID
- DesiReS / 2017019-11DX
- Conditions
- Scleroderma, Systemic, Skin Sclerosis, Lung Fibrosis, Autoimmune Diseases, Collagen Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development, Zenyaku Kogyo Co., Ltd.
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 18 Feb 2020 (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.
This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-Blind Placebo | Placebo comparator | Drug: Double-Blind PlaceboParticipants will receive double-blind matching placebo from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48. |
| Double-Blind Rituximab | Experimental | Drug: Double-Blind RituximabParticipants will receive double-blind rituximab from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fulfill the diagnostic criteria for systemic sclerosis defined in the 2016 edition of the Clinical Practice Guidelines for Systemic Sclerosis and have an mRTSS of 2 (moderate) or higher for skin sclerosis
- Aged 20 or older and younger than 80 at the time of consent
- Have an expected survival of at least 6 months (and expected to allow 6 months of observation)
- Fulfill the following criteria related to concomitant medications/therapies:
- Provided written consent to participate in the study
Key exclusion criteria (21 listed)
- Present with pulmonary hypertension* associated with systemic sclerosis
- : The patient will undergo echocardiography during the pre-treatment observation period to exclude pulmonary hypertension. The patient will be required to undergo examination by an expert (eg, at the Department of Cardiovascular Medicine) if systolic pulmonary artery pressure exceeds 35 mmHg.
- Have serious complications (eg, renal crisis) associated with systemic sclerosis (excluding interstitial pneumonia**)
- : Patients with interstitial pneumonia will be excluded if the criterion 3) below is met.
- Have only poor respiratory reserve (%VC or %DLco, both calculated using the "estimation equation more suitable for Japanese," is less than 60% or 40%, respectively)
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 |
|---|---|---|
| Double-Blind PlaceboThe 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment. In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered. | Drug | Double-Blind Placebo |
| Double-Blind RituximabThe 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment. In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered. | Drug | Double-Blind Rituximab |
Primary outcome
Change in Modified Rodnan Total Skin Thickness Score (mRTSS) during double-blind period
Time frame: From baseline to week 24
Absolute change from pre-treatment observation period in skin sclerosis at week 24 of treatment in the double-blind phase, assessed by mRTSS. mRTSS ranging from 0 (normal) to 3 (severe skin thickening) across 17 different body parts. The total score is the sum of the individual skin scores for all these sites, and ranges from 0 to 51 units.
40 secondary outcomes
Change in percent FVC measured in respiratory function test
Time frame: From baseline to week 24
Change in percent DLco measured in respiratory function test
Time frame: From baseline to week 24
Change in TLC measured in respiratory function test
Time frame: From baseline to week 24
Change in serum levels of KL-6
Time frame: From baseline to week 24
Change in serum levels of SP-D
Time frame: From baseline to week 24
Change in serum levels of SP-A
Time frame: From baseline to week 24
Change in percentage of interstitial shadow in lungs by high-resolution computed tomography
Time frame: From baseline to week 24
Change in skin thickness measured following biopsy specimen
Time frame: From baseline to week 24
Change in HRQOL index measured using MOS 36 Item Short-Form Health Survey
Time frame: From baseline to week 24
Change in QOL index of SSc patients, assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: From baseline to week 24
Change in serum antinuclear antibody titers
Time frame: From baseline to week 24
Change in serum levels of anti-centromere antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-Scl-70 antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-RNA polymerase III antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-ssDNA antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-dsDNA antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-CL antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-β2-GP1 antibodies
Time frame: From baseline to week 24
Change in serum levels of lupus anticoagulant
Time frame: From baseline to week 24
Change in serum levels of anti-SS-A antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-SS-B antibodies
Time frame: From baseline to week 24
Change in serum levels of anti-cANCA
Time frame: From baseline to week 24
Change in serum levels of anti-p-ANCA
Time frame: From baseline to week 24
Change in serum levels of anti-U1-RNP antibodies
Time frame: From baseline to week 24
Change in serum levels of IgG
Time frame: From baseline to week 24
Change in serum levels of IgM
Time frame: From baseline to week 24
Change in serum levels of IgA
Time frame: From baseline to week 24
Change in blood CD19+ B cell count
Time frame: From baseline to week 24
Change in blood CD20+ B cell count
Time frame: From baseline to week 24
Change in blood CD3+ T cell count
Time frame: From baseline to week 24
Expression of human anti-rituximab antibodies
Time frame: From baseline to week 24
Overall incidence, severity, causal relationship, and outcome of adverse events
Time frame: From baseline to week 48
Incidence of rituximab infusion reactions
Time frame: From baseline to week 48
PK profile of rituximab: Area under concentration-time curve from time 0 to final observation (AUC0-t)
Time frame: From baseline to week 48
PK profile of rituximab: maximum serum concentration after dosing (Cmax)
Time frame: From baseline to week 48
PK profile of rituximab: time to maximum concentration (tmax)
Time frame: From baseline to week 48
PK profile of rituximab: terminal half-life (t1/2)
Time frame: From baseline to week 48
PK profile of rituximab: mean residence time
Time frame: From baseline to week 48
PK profile of rituximab: clearance
Time frame: From baseline to week 48
PK profile of rituximab: volume of distribution
Time frame: From baseline to week 48
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 18 Feb 2020.
- Derived from this study: PubMed 38294008Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Okiyama N, Kodera M, Hasegawa M, Sato S. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): open-label extension of a double-blind, investigators-initiated, randomised, placebo-controlled trial. Lancet Rheumatol. 2022 Aug;4(8):e546-e555. doi: 10.1016/S2665-9913(22)00131-X. Epub 2022 Jun 28.
- Derived from this study: PubMed 38279402Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Asano Y, Okiyama N, Kodera M, Hasegawa M, Sato S. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): a double-blind, investigator-initiated, randomised, placebo-controlled trial. Lancet Rheumatol. 2021 Jul;3(7):e489-e497. doi: 10.1016/S2665-9913(21)00107-7. Epub 2021 May 26.
- Derived from this study: PubMed 35136981Ebata S, Oba K, Kashiwabara K, Ueda K, Uemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Yoshihide A, Yoshizaki A, Sato S. Predictors of rituximab effect on modified Rodnan skin score in systemic sclerosis: a machine-learning analysis of the DesiReS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4364-4373. doi: 10.1093/rheumatology/keac023.
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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.
Ayumi Yoshizaki, MD, PhD principal investigator
Tokyo University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Double-Blind Rituximab in people with Scleroderma, Systemic and Skin Sclerosis, run by Tokyo University at 4 sites in Japan.
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 7 inclusion and 21 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 18 Feb 2020. 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 Japan. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Modified Rodnan Total Skin Thickness Score (mRTSS) during double-blind period (time frame: From baseline to week 24). 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 NCT04274257, which also lists 3 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 18 Feb 2020.