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AsthmaPhase 3NCT03629249

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

A Phase 3 study testing QAW039 150 mg once daily and QAW039 450 mg once daily in people with Asthma, run by Novartis Pharmaceuticals at 120 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Asthma
What is being tested?
QAW039 150 mg once daily and QAW039 450 mg once daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
604 participants
Where
120 sitesin 21 countries
Study dates
13 Dec 2018to 6 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening Visit with current asthma severity step 4 or 5 (GINA 2018)
  • Currently on treatment with medium or high dose ICS/LABA +/- other controller (i.e.long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA) etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit
  • At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-In Visit
  • An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility was accepted).
  • Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit
  • Documented history of at least 1 asthma exacerbation within 1 year prior to enrollment

Who cannot join

  • Asthma exacerbation, within 6 weeks prior to enrollment (screening) that required SCS, hospitalization, or emergency room visit
  • Chronic/maintenance use of oral corticosteroids (OCS) for asthma (total OCS use days greater than 6 months; continuously or intermittently) within the last year
  • Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period.
  • Any contraindications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician
  • Pregnant or nursing (lactating) women
  • Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days], whichever is longer

Trial locations and contacts

120 sites in 21 countries.

120 sites in 21 countries

Germany20 sites

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 10969

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hanover, 30173

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Argentina14 sites

  • Novartis Investigative Site

    Buenos Aires, 1428

  • Novartis Investigative Site

    Buenos Aires, 1900

  • Novartis Investigative Site

    Buenos Aires, C1012AAR

  • Novartis Investigative Site

    Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Buenos Aires, C1440BRR

  • Novartis Investigative Site

    CABA, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    CABA, Buenos Aires, C1424BSF

  • Novartis Investigative Site

    CABA

  • Novartis Investigative Site

    Córdoba, X5003DCE

  • Novartis Investigative Site

    Florida, Buenos Aires, B1602DQD

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

Other trials in Argentina

Russia12 sites

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 115682

  • Novartis Investigative Site

    Moscow, 125993

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Saint Petersburg, 193312

  • Novartis Investigative Site

    Saint Petersburg, 194325

  • Novartis Investigative Site

    Saint Petersburg, 196143

  • Novartis Investigative Site

    Saint Petersburg, 198260

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Stavropol, 355000

  • Novartis Investigative Site

    Volgograd, 400120

Other trials in Russia

Hungary10 sites

  • Novartis Investigative Site

    Balassagyarmat, 2660

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Győr, HUN, 9024

  • Novartis Investigative Site

    Hajdúnánás, HUN, 4080

  • Novartis Investigative Site

    Kapuvár, HUN, 9330

  • Novartis Investigative Site

    Nyíregyháza, H-4400

  • Novartis Investigative Site

    Pécs, 7635

  • Novartis Investigative Site

    Püspökladány, HUN, 4150

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440

  • Novartis Investigative Site

    Szeged, 6722

Other trials in Hungary

United States9 sites

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Boerne, Texas, 78006

  • Novartis Investigative Site

    Dallas, Texas, 75230

  • Novartis Investigative Site

    McKinney, Texas, 75069

  • Novartis Investigative Site

    Newport Beach, California, 92663

  • Novartis Investigative Site

    The Bronx, New York, 10459

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

  • Novartis Investigative Site

    Westminster, California, 92683

  • Novartis Investigative Site

    Winter Park, Florida, 32789

Other trials in United States

Czechia7 sites

  • Novartis Investigative Site

    Beroun, Czech Republic, 266 01

  • Novartis Investigative Site

    Jindřichův Hradec, 377 01

  • Novartis Investigative Site

    Lovosice, 41002

  • Novartis Investigative Site

    Prague, Czech Republic, 140 46

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Teplice, CZE, 415 01

  • Novartis Investigative Site

    Varnsdorf, 40747

Other trials in Czechia

Greece5 sites

  • Novartis Investigative Site

    Athens, GR, 115 25

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

Other trials in Greece

Slovakia5 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Levice, Slovak Republic, 934 01

  • Novartis Investigative Site

    Spišská Nová Ves, Slovak Republic, 052 01

  • Novartis Investigative Site

    Žilina, 010 01

Other trials in Slovakia

Belgium4 sites

  • Novartis Investigative Site

    Erpent, 5100

  • Novartis Investigative Site

    Lebbeke, 9280

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Mechelen, 2800

Other trials in Belgium

Colombia4 sites

  • Novartis Investigative Site

    Bogotá, 110221

  • Novartis Investigative Site

    Bogotá, 110231

  • Novartis Investigative Site

    Bucaramanga

  • Novartis Investigative Site

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

France4 sites

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Lyon, Rhone, 69317

  • Novartis Investigative Site

    Montpellier, Herault, 34059

  • Novartis Investigative Site

    Pessac, 33604

Other trials in France

Peru4 sites

  • Novartis Investigative Site

    Cusco, 84

  • Novartis Investigative Site

    Lima, 1

  • Novartis Investigative Site

    Piura

  • Novartis Investigative Site

    San Isidro, Lima region, 27

Other trials in Peru

Spain4 sites

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Marbella, Andalusia, 29603

  • Novartis Investigative Site

    Santiago de Compostela, 15706

Other trials in Spain

Bulgaria3 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Vidin, BGR, 3703

Other trials in Bulgaria

Philippines3 sites

  • Novartis Investigative Site

    Iloilo City, Iloilo, 5000

  • Novartis Investigative Site

    Iloilo City, 5000

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

Other trials in Philippines

United Kingdom3 sites

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ

  • Novartis Investigative Site

    Chertsey, Surrey, KT16 0PZ

  • Novartis Investigative Site

    Portsmouth, Hants, PO6 3LY

Other trials in United Kingdom

Vietnam3 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Hanoi, 10000

  • Novartis Investigative Site

    Ho Chi Minh City

Other trials in Vietnam

Chile2 sites

  • Novartis Investigative Site

    Curicó, Maule Region, 3341643

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500692

Other trials in Chile

South Africa2 sites

  • Novartis Investigative Site

    Berea, Durban, 4001

  • Novartis Investigative Site

    Cape Town, 7925

Other trials in South Africa

Thailand1 site

  • Novartis Investigative Site

    Bangkok, 10400

Other trials in Thailand

Turkey (Türkiye)1 site

  • Novartis Investigative Site

    Mersin, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma

The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.

Read the detailed description

This was a randomized, multicenter, double-blind, double-dummy, placebo-controlled, parallel-group study to determine the ability of fevipiprant (QAW039) plus standard-of-care (SoC) compared with placebo plus SoC to reduce the use of systemic corticosteroids (SCS) in patients with severe asthma. The study included:

  • a Screening period of up to 2 weeks to assess eligibility;
  • a Run-in period of 4 or 10 weeks to evaluate maintenance of asthma control and to collect baseline safety data. The Run-in period was 4 weeks for patients coming with high-dose ICS/LABA (inhaled corticosteroids/long-acting beta-agonist) and 10 weeks for patients switching from mid-dose to high-dose ICS/LABA as per protocol during the run-in period;
  • a Treatment period of 52 weeks. Upon completion of the Run-in period, all patients who met eligibility criteria were randomized to 1 of 3 treatment groups (fevipiprant 150 mg or 450 mg or placebo once daily) in a ratio 1:1:1. Randomized patients were stratified according to their peripheral blood eosinophil count (< 250 cells/μl or ≥ 250 cells/μl);
  • a Follow-up period of 2 weeks following the last dose of study drug to collect additional data for safety variables.

The main purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to GINA (Global Initiative for Asthma) treatment step 4 or 5 SoC asthma therapy in terms of avoidance of SCS use over 52 weeks in patients with inadequately controlled severe asthma and high eosinophil counts (eosinophil count at Visit 1 ≥250 cells/ μl) and in the overall patient population regardless of eosinophil counts.

On 16-Dec-2019 the sponsor decided to terminate study CQAW039A2323 earlier than the planned study completion. There were no safety findings with fevipiprant that contributed to this decision. The planned treatment period of 52 weeks was not completed by any patient; patients were treated for a median time of 14 weeks in each group and a maximum of up to 36 weeks.

Conditions
Asthma
Being tested
Placebo once daily, QAW039 150 mg once daily, QAW039 450 mg once daily
Keywords
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immune System Diseases, Fevipiprant, QAW039
Medical subject headings
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Hypersensitivity, Hypersensitivity, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo once dailyDrug

    Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 150 mg and one tablet blinded placebo to QAW039 450 mg).

  • QAW039 150 mg once dailyDrug

    Also called fevipiprant 150 mg

    QAW039 150 mg once daily (one tablet of blinded QAW039 150 mg to be given together with one tablet blinded placebo to QAW039 450 mg)

  • QAW039 450 mg once dailyDrug

    Also called fevipiprant 450 mg

    QAW039 450 mg once daily (one tablet of blinded QAW039 450 mg to be given together with one tablet blinded placebo to QAW039 150 mg)

Study groups in NCT03629249
Study groupRoleWhat they receive
QAW039 150 mgExperimentalQAW039 150 mg once daily orally
Receives: Drug: QAW039 150 mg once daily
QAW039 450 mgExperimentalQAW039 450 mg once daily orally
Receives: Drug: QAW039 450 mg once daily
PlaceboPlacebo comparatorPlacebo to QAW039 once daily orally
Receives: Drug: Placebo once daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population

    All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

    The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120*12/3=480mg total SCS dose.

    The mean values over 52 weeks in the overall patient population regardless of peripheral blood eosinophil counts are reported here.

    Measured: 52 weeks

  2. Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl)

    All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

    The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120*12/3=480mg total SCS dose.

    The mean values over 52 weeks in the subpopulation of patients with high peripheral blood eosinophil count at baseline are reported here.

    Measured: 52 weeks

Secondary outcomes (7)

  1. Change From Baseline in Daytime Symptom Scores

    All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening.

    The daytime asthma symptom score included 4 questions with a range of response categories for each question from 0 to 6 (0 = totally controlled; 6 = extremely poorly controlled). The questions were equally weighted and the overall score (from 0 to 6) was calculated as the average of the 4 questions with higher values indicating more asthma symptoms.

    Mean values of daytime asthma symptom scores were calculated over 4-week intervals during the treatment period.

    The baseline values of daytime asthma symptoms scores were defined as the average score during the run-in period.

    A negative change from baseline in daytime asthma symptom score is a favorable outcome.

    Measured: Baseline, up to Week 29-32

  2. Change From Baseline in Nighttime Symptom Scores

    All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening.

    The nighttime asthma symptom score included 1 question with a range of response categories from 0 to 3 (0 = no awakening with asthma symptoms; 3 = awake all night).

    Mean values of nighttime asthma symptom scores were calculated over 4-week intervals during the treatment period.

    The baseline values of nighttime asthma symptoms scores were defined as the average score during the run-in period.

    A negative change from baseline in nighttime asthma symptom score is a favorable outcome.

    Measured: Baseline, up to Week 29-32

  3. Change From Baseline in ACQ-5 Total Score up to End of Treatment Visit

    The Asthma Control Questionnaire (ACQ-5) was completed by the patients at the investigator's site. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions were equally weighted and the ACQ-5 score was the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

    The baseline values of ACQ-5 score were defined as the ACQ-5 scores obtained on Day 1.

    A negative change from baseline in ACQ-5 score is a favorable outcome.

    Measured: Baseline, up to Week 28

  4. Change From Baseline in AQLQ+12 Total Score up to End of Treatment Visit

    The Asthma Quality of Life Questionnaire (AQLQ+12) was completed by the patients at the investigator's site. The AQLQ+12 is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. Patients were asked to recall their experiences during the previous 2 weeks and to score each of the 32 items on a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. Each item of the AQLQ+12 was equally weighted and the overall score was the mean score of all 32 items and therefore ranged between 1 and 7.

    The baseline values of AQLQ+12 score were defined as the AQLQ+12 scores obtained on Day 1.

    A positive change from baseline in AQLQ+12 score is a favorable outcome.

    Measured: Baseline, up to Week 28

  5. Percentage of Patients Requiring ≥ 7.5 mg Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Per Day Continuously for at Least 30 Days

    All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

    The percentage of patients requiring ≥ 7.5 mg systemic corticosteroid dose in mg prednisone/prednisolone (or equivalent) per day continuously for at least 30 days within the on-treatment period is presented in this record.

    Measured: Up to 36 weeks

  6. Percentage of Patients With no Systemic Corticosteroids Use

    All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

    The percentage of patients with no systemic corticosteroids use up to visit on Week 36 is presented in this record.

    Measured: Week 36

  7. Percentage of Patients With Prescription of Biologic Therapy

    As part of the flexible therapy, investigators were allowed to prescribe biologics approved for asthma from randomization visit onwards. Prescription of biologic therapy during the treatment period was recorded.

    The proportion of patients with prescription of biologic therapy during the on-treatment period is presented in this record.

    Measured: Up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start13 Dec 2018
  3. Primary completion6 Feb 2020
  4. Study completion6 Feb 2020

Why it stopped: Company decision

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03629249
Sponsor's protocol ID
CQAW039A2323
Other IDs
2018-000212-25, 2018
Status last verified
Oct 2021
First submitted
9 Aug 2018
Last updated
11 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QAW039 150 mg once daily and QAW039 450 mg once daily in people with Asthma, run by Novartis Pharmaceuticals at 120 sites in 21 countries.

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 6 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in Germany, Argentina, Russia, Hungary, United States and 16 more countries. 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 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?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population (time frame: 52 weeks). The study lists 2 primary outcomes in all. 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 NCT03629249.

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 11 Oct 2021.

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