Idiopathic Pulmonary FibrosisPhase 2ELEVATENCT05321420
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Pirfenidone and Deupirfenidone in people with Idiopathic Pulmonary Fibrosis, run by PureTech at 103 sites in 14 countries.
Trial summary
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone and Deupirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 103 sitesin 14 countries
- Study dates
- 22 Jul 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naïve patients or those with <6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
- DLCO corrected for Hemoglobin (Hb) [visit 1] ≥ 30% and ≤90% of predicted of normal
- FVC ≥ 45% of predicted normal
Who cannot join
- Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1)
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
- Cardiovascular diseases, any of the following:
- Uncontrolled hypertension, within 3 months of Visit 1
Show all 9Show fewer
- Myocardial infarction within 6 months of Visit 1
- Unstable cardiac angina within 6 months of Visit 1
- Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
Trial locations and contacts
103 sites in 14 countries.
103 sites in 14 countries
United States22 sites
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309
University of Alabama Birmingham
Birmingham, Alabama, 35294
University of Cincinnati
Cincinnati, Ohio, 45267
Baylor Scott & White Research Institute
Dallas, Texas, 75204
Clinical Research Investments
Decatur, Georgia, 30030
Accel Research Sites Network
DeLand, Florida, 32720
University of Connecticut Health Center
Farmington, Connecticut, 06030
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
Pulmonix
Greensboro, North Carolina, 27403
Harmony Medical Research Institute, Inc
Hialeah, Florida, 33016
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Science 37
Los Angeles, California, 90230
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
NewportNativeMD, Inc.
Newport Beach, California, 92663
Temple University
Philadelphia, Pennsylvania, 19140
Paradigm Clinical Research Centers, Inc.
Redding, California, 96001
Pulmonary Associates of Richmond
Richmond, Virginia, 23230
Renovatio Clinical - The Woodlands Research Center
The Woodlands, Texas, 77380
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502
TPMG Clinical Research
Williamsburg, Virginia, 23188
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Argentina14 sites
Aprillus Asistencia e Investigación
Buenos Aires, 1406
CEMER Centro Medico de Enfermedades Respiratorias
Buenos Aires, 1602
Instituto de Medicina Respiratoria - IMER
Córdoba, X5003DCE
Respira Salud Clinica Integral
Godoy Cruz, 5501
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600
Polo de Salud Vistalba
Mendoza, 1428
CIMRO- Centro de Investigación Médica Respiratoria Oncológica
Mendoza, 5600
INSARES - Instituto de Salud Respiratoria
Mendoza, M5500CCG
Centro Médico Dharma
Mendoza, M5500
Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios
Rosario, Santa Fe Province, 2000
Instituto de Enfermedades Respiratorias e Investigación Clínica
San Juan Bautista, 1888
Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, 4000
Instituto del Buen Aire
Santa Fe, 3000
Clinica Central S.A.
Villa Regina, 8336
South Korea13 sites
The Catholic University Of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
InJe University Haeundae Paik Hospital
Busan, 48108
Keimyung University - Dongsan Medical Center
Daegu, 42601
Hanyang University - Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Chonnam National University Hospital
Gwangju, 61469
CHA Bundang Medical Center
Gyeonggi-do, 13496
Gachon University Gil Medical Center
Incheon, 21565
Kyung Hee University Hospital
Seoul, 02447
Hanyang University Seoul Hospital
Seoul, 04763
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Ulsan University Hospital
Ulsan, 44033
India10 sites
BHS Lakeview Heart
Belagāve, 590016
Sparsh Super Specialty Hospital
Bengaluru, Karnataka, 560001
Mgm Medical College And Hospital, Aurangabad
Chhatrapati Sambhajinagar, Maharashtra, 431003
Government Medical College and Hospital Aurangabad
Chhatrapati Sambhajinagar, Maharashtra, 431004
Oriion Citicare Super Specialty Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431005
Govt. General and Chest Hospital
Hyderabad, Telangana, 500038
Apollo Spectra Hospital
Kanpur, Uttar Pradesh, 208001
Nil Ratan Sircar Medical College And Hospital, Kolkata
Kolkata, West Bengal, 700014
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012
Rhythm Heart Institute Vadodara
Vadodara, Gujarat, 390022
Greece6 sites
University Hospital Alexandroupolis
Alexandroupoli, 68100
"Sotiria" Chest Diseases Hospital of Athens
Athens, 11527
University General Hospital "Attikon"
Athens, 12462
Athens Medical Center
Athens, 15125
University General Hospital of Patras
Pátrai, 26504
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
Malaysia6 sites
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Hospital Pulau Pinang
George Town, 10450
Hospital Serdang
Kajang
Institut Perubatan Respiratori
Kuala Lumpur
University Malaya Medical Centre
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
Georgia5 sites
National Ceneter for Tuberculosis and Lung Diseases JSC
Tbilisi, 0101
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 0144
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, 0159
LTD Aversi Clinic
Tbilisi, 0160
LTD The First Medical Center
Tbilisi, 0180
Mexico5 sites
CALPULAB
Calpulalpan, 90204
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460
Oaxaca Site Management Organization
Oaxaca City, 68000
Integral Health Medical Unit
San Nicolás de los Garza, Nuevo León, 66465
ONCARE Group
San Pedro Garza García, 66220
South Africa5 sites
Durban Lung Centre
Durban, 4051
WITS Clinical Research
Johannesburg, 2193
Ahmed Kathrada Lenmed Private Hospital
Johannesburg
Netcare Milpark Hospital
Parktown, 2193
Ryexo Clinical Research
Pretoria, 0084
Chile4 sites
Clinica Maule
Maule, 3530000
Centro de Estudios Clinicos
Santiago, 7550000
Clinica Universidad de Los Andes
Santiago, 7550000
Centro Respiratorio Integral
Valparaíso
Thailand4 sites
Siriraj Hospital
Bangkok
Khon Kaen University
Khon Kaen
Central Chest Institute Of Thailand
Nonthaburi
Songklanagarind Hospital
Songkhla
Colombia3 sites
Fundacion Cardiomet CEQUIN
Armenia
Instituto Neumologico del Oriente S.A.
Bucaramanga
Centro de Investigaciones Clinicas S.A.S
Cali, 760036
Philippines3 sites
St. Luke's Medical Center - Global City
City of Taguig, 1634
Philippine General Hospital
Manila, 1000
Lung Center of the Philippines
Quezon City, 1100
Romania3 sites
S.C. Netconsult SRL
Iași, 700141
S.C. Lavinia Davidescu Clinic SRL
Oradea, 410163
"Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology
Timișoara, 300312
About this study
Official title: A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
Read the detailed description
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Placebo, Pirfenidone, Deupirfenidone
- Keywords
- IPF, lung fibrosis, respiratory disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
PirfenidoneDrug
pirfenidone 801 mg TID
DeupirfenidoneDrug
Deupirfenidone
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo oral administration Receives: Drug: Placebo |
| pirfenidone 801 mg TID | Active comparator | pirfenidone 801 mg TID oral administration Receives: Drug: Pirfenidone |
| LYT-100 550 mg TID | Experimental | LYT-100 (Deupirfenidone) 550 mg TID oral administration Receives: Drug: Deupirfenidone |
| LYT-100 825 mg TID | Experimental | LYT-100 (Deupirfenidone) 825 mg TID oral administration Receives: Drug: Deupirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
Rate of decline in Forced Vital Capacity (FVC; in mL)
Measured: 26 weeks
Secondary outcomes (6)
Forced Vital Capacity (FVC) percent predicted change (Part A)
FVC percent predicted (FVCpp) change from baseline to Week 26
Measured: Baseline to Week 26
Time to hospitalization or mortality (Part A)
Time to hospitalization or mortality due to respiratory cause through 26 weeks
Measured: 26 weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)
Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death
Measured: 26 weeks
Forced Vital Capacity (FVC) percent predicted change (Part B)
FVC percent predicted (FVCpp) change from Week 26 to Week 52
Measured: 26 Weeks
Rate of decline in Forced Vital Capacity over 26 weeks (Part B)
Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52
Measured: 26 Weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)
Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start22 Jul 2022
- Primary completion15 Oct 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camilla Graham, MD, Study director, PureTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321420
- Sponsor's protocol ID
- LYT-100-2022-204
- Acronym
- ELEVATE
- Status last verified
- Oct 2025
- First submitted
- 2 Apr 2022
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher TM, Hamblin MJ, Choi WI, Case AH, Tomos IP, Tzouvelekis AE, Shore JE, Bergna MA, Golod D, Elenko E, Zhang Y, Graham CS, Song JW, Kulkarni T; and the ELEVATE IPF Investigators. Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial. Am J Respir Crit Care Med. 2026 Aug 1;212(8):1761-1769. doi: 10.1093/ajrccm/aamag155.
PubMed 42085224
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT05321420
- Acronym / sponsor ID
- ELEVATE / LYT-100-2022-204
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, lung fibrosis, respiratory disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- PureTechIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Apr 2022 (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 a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
Detailed description
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral administration |
| pirfenidone 801 mg TID | Active comparator | Drug: Pirfenidonepirfenidone 801 mg TID oral administration |
| LYT-100 550 mg TID | Experimental | Drug: DeupirfenidoneLYT-100 (Deupirfenidone) 550 mg TID oral administration |
| LYT-100 825 mg TID | Experimental | Drug: DeupirfenidoneLYT-100 (Deupirfenidone) 825 mg TID oral administration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment naïve patients or those with <6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
- DLCO corrected for Hemoglobin (Hb) [visit 1] ≥ 30% and ≤90% of predicted of normal
- FVC ≥ 45% of predicted normal
Key exclusion criteria (9 listed)
- Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1)
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
- Cardiovascular diseases, any of the following:
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 |
|---|---|---|
| Placeboplacebo | Drug | Placebo |
| Pirfenidonepirfenidone 801 mg TID | Drug | pirfenidone 801 mg TID |
| DeupirfenidoneDeupirfenidone | Drug | LYT-100 550 mg TID, LYT-100 825 mg TID |
Primary outcome
Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
Time frame: 26 weeks
Rate of decline in Forced Vital Capacity (FVC; in mL)
6 secondary outcomes
Forced Vital Capacity (FVC) percent predicted change (Part A)
Time frame: Baseline to Week 26
Time to hospitalization or mortality (Part A)
Time frame: 26 weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)
Time frame: 26 weeks
Forced Vital Capacity (FVC) percent predicted change (Part B)
Time frame: 26 Weeks
Rate of decline in Forced Vital Capacity over 26 weeks (Part B)
Time frame: 26 Weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)
Time frame: 26 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Derived from this study: PubMed 42085224Maher TM, Hamblin MJ, Choi WI, Case AH, Tomos IP, Tzouvelekis AE, Shore JE, Bergna MA, Golod D, Elenko E, Zhang Y, Graham CS, Song JW, Kulkarni T; and the ELEVATE IPF Investigators. Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial. Am J Respir Crit Care Med. 2026 Aug 1;212(8):1761-1769. doi: 10.1093/ajrccm/aamag155.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Camilla Graham, MD study director
PureTech
103 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone and Deupirfenidone in people with Idiopathic Pulmonary Fibrosis, run by PureTech at 103 sites in 14 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Argentina, South Korea, India, Greece and 9 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of decline in Forced Vital Capacity over 26 weeks (Part A) (time frame: 26 weeks). 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 NCT05321420, which also lists 1 linked publication.
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 16 Oct 2025.