AsthmaPhase 2READY-BREATHENCT07746687
A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma
A Phase 2 study testing JNJ-95597528 in people with Asthma, run by Janssen Research & Development, LLC at 19 sites in 5 countries.
Trial summary
The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma
- What is being tested?
- JNJ-95597528
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 5 Oct 2026to 1 Jul 2030
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline
- Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (>=) 200 milliliter (mL) and >=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) >=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after >=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by >=12% and >=200 mL, or increase in PEF by >=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: >=20% decrease from baseline in FEV1 with standard doses of methacholine, or >=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of >10% and >200 mL with standardized exercise challenge
- Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose >=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose >=250 to 500 mcg fluticasone propionate or equivalent
- Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist [LABA], long-acting muscarinic antagonist [LAMA] [can be combined with ICS in 1 inhaler or can be separate inhalers], leukotriene receptor antagonist [LTRA])
- Asthma control questionnaire, 5-item (ACQ-5) score >=1.5 at the screening visit and the baseline visit
Who cannot join
- History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment
- Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts
- Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling
- Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma
- Current smokers or former smokers with a smoking history >=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 5 countries
United States7 sites, 7 recruiting
- Recruiting
Boston Specialists
Boston, Massachusetts, 02111
- Recruiting
OK Clinical Research
Edmond, Oklahoma, 73034
- Recruiting
Clinical Research Institute
Minneapolis, Minnesota, 55402
- Recruiting
Allergy Asthma and Clinical Research Center Martha Tarpay MD
Oklahoma, Texas, 73120
- Recruiting
Midwest Clinical Research LLC
St Louis, Missouri, 63141
- Recruiting
Equity Medical
The Bronx, New York, 10455
- Recruiting
Allianz Research Institute, Inc.
Westminster, California, 92683
Argentina5 sites, 5 recruiting
- Recruiting
INAER - Investigacion en Alergias y Enfermedades Respiratorias
Buenos Aires, C1425
- Recruiting
Instituto de Medicina Respiratoria IMER
Córdoba, X5003DCE
- Recruiting
Fundacion Scherbovsky
Mendoza, 5500
- Recruiting
Instituto De Especialidades De La Salud SRL
Rosario, S2000DBS
- Recruiting
IBAMEDICA Propiedad de IBA Santa Fe S.A.S
Santa Fe, S3000ASF
China4 sites, 4 recruiting
- Recruiting
China Japan Friendship Hospital
Beijing, 100013
- Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, 213000
- Recruiting
Ningbo medical center lihuili hospital
Ningbo, 315041
- Recruiting
Shanxi Bethune Hospital
Taiyuan, 030032
Japan2 sites, 2 recruiting
- Recruiting
Idaimae Minami4jo Internal Medicine
Sapporo, 064 0804
- Recruiting
Tokyo Shinagawa Hospital
Shinagawa City, 140-8522
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6492415
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma
The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).
- Conditions
- Asthma
- Being tested
- JNJ-95597528, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-95597528Drug
JNJ-95597528 will be administered as subcutaneous (SC) injection.
PlaceboDrug
Placebo will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: JNJ-95597528: Dose 1 | Experimental | Participants will receive JNJ-95597528 Dose 1 at Weeks 0, 2, 12, 24 and 36. Receives: Drug: JNJ-95597528 |
| Group 2: JNJ-95597528: Dose 2 and Dose 3 | Experimental | Participants will receive JNJ-95597528 Dose 2 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 3 at Weeks 12, 24 and 36. Receives: Drug: JNJ-95597528; Drug: Placebo |
| Group 3: JNJ-95597528: Dose 4 and 5 | Experimental | Participants will receive JNJ-95597528 Dose 4 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 5 at Weeks 12, 24 and 36. Receives: Drug: JNJ-95597528; Drug: Placebo |
| Group 4: Placebo | Placebo comparator | Participants will receive matching placebo doses at Weeks 0, 2, 12, 24, and 36. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Asthma Exacerbations Through Week 48
Participant who experiences intercurrent events (ICEs) in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have an asthma exacerbation. An asthma exacerbation is defined as a worsening of asthma that requires a medical intervention and/or results in death. A worsening of asthma is defined as: worsening of asthma signs/symptoms; increased use of 'as needed' reliever medication; deterioration of lung function that is, peak expiratory flow, forced expiratory volume in 1 second (FEV1).
Measured: Up to Week 48
Secondary outcomes (6)
Time to First Asthma Exacerbation Event From Week 0 Through Week 48
Time to first asthma exacerbation event from Week 0 through Week 48 will be reported. A participant is considered to have an asthma exacerbation if the participant experiences ICEs in categories 5 or 6 after treatment initiation and prior to Week 48.
Measured: From Week 0 Through Week 48
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 48
Change from baseline in pre-bronchodilator FEV1 at Weeks 2, 12, 24, and 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have a zero change from baseline in pre-BD FEV1 at Weeks 2, 12, 24, and 48 will be reported.
Measured: Baseline, Week 2, 12, 24, and 48
Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48
Change from baseline in FeNO at Weeks 2, 12, 24, and 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline in FeNO at Weeks 2, 12, 24, and 48 will be reported. FeNO is a non-invasive breath test that provides an objective measure of type 2 airway inflammation. High FeNO levels have been shown to predict increased risk of acute exacerbations in participants with moderate to severe asthma.
Measured: Baseline, Week 2, 12, 24, and 48
Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48
Change from baseline in ACQ-5 at Week 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline will be reported. The ACQ is a validated, 5-item, patient-reported tool used to measure asthma control and treatment effectiveness over the past week. Each item has with 7 response categories ranging from 0 to 6. The ACQ-5 is scored by computing the average of the 5 items. The final score ranges from 0 (well-controlled) to 6 (extremely poorly controlled).
Measured: Baseline, Week 48
Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48
Mean change from baseline in the 7-day mean daily asthma daily diary score at Week 48 will be reported. A participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline.
Measured: Baseline, Week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, except: hospitalizations not intended to treat an acute illness or AE; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Measured: Up to 90 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Oct 2026
- Primary completion11 Sep 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746687
- Sponsor's protocol ID
- 95597528ASH2001
- Other IDs
- 2026-526262-24-00
- Acronym
- READY-BREATHE
- Status last verified
- Nov 2026
- First submitted
- 31 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT07746687
- Acronym / sponsor ID
- READY-BREATHE / 95597528ASH2001
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 11 Sep 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 5 Aug 2026 (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.
The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).
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 |
|---|---|---|
| Group 1: JNJ-95597528: Dose 1 | Experimental | Drug: JNJ-95597528Participants will receive JNJ-95597528 Dose 1 at Weeks 0, 2, 12, 24 and 36. |
| Group 2: JNJ-95597528: Dose 2 and Dose 3 | Experimental | Drug: JNJ-95597528, Drug: PlaceboParticipants will receive JNJ-95597528 Dose 2 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 3 at Weeks 12, 24 and 36. |
| Group 3: JNJ-95597528: Dose 4 and 5 | Experimental | Drug: JNJ-95597528, Drug: PlaceboParticipants will receive JNJ-95597528 Dose 4 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 5 at Weeks 12, 24 and 36. |
| Group 4: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo doses at Weeks 0, 2, 12, 24, and 36. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline
- Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (>=) 200 milliliter (mL) and >=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) >=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after >=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by >=12% and >=200 mL, or increase in PEF by >=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: >=20% decrease from baseline in FEV1 with standard doses of methacholine, or >=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of >10% and >200 mL with standardized exercise challenge
- Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose >=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose >=250 to 500 mcg fluticasone propionate or equivalent
- Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist [LABA], long-acting muscarinic antagonist [LAMA] [can be combined with ICS in 1 inhaler or can be separate inhalers], leukotriene receptor antagonist [LTRA])
- Asthma control questionnaire, 5-item (ACQ-5) score >=1.5 at the screening visit and the baseline visit
Key exclusion criteria (5 listed)
- History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment
- Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts
- Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling
- Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma
- Current smokers or former smokers with a smoking history >=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes
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 |
|---|---|---|
| JNJ-95597528JNJ-95597528 will be administered as subcutaneous (SC) injection. | Drug | Group 1: JNJ-95597528: Dose 1, Group 2: JNJ-95597528: Dose 2 and Dose 3, Group 3: JNJ-95597528: Dose 4 and 5 |
| PlaceboPlacebo will be administered as SC injection. | Drug | Group 2: JNJ-95597528: Dose 2 and Dose 3, Group 3: JNJ-95597528: Dose 4 and 5, Group 4: Placebo |
Primary outcome
Number of Asthma Exacerbations Through Week 48
Time frame: Up to Week 48
Participant who experiences intercurrent events (ICEs) in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have an asthma exacerbation. An asthma exacerbation is defined as a worsening of asthma that requires a medical intervention and/or results in death. A worsening of asthma is defined as: worsening of asthma signs/symptoms; increased use of 'as needed' reliever medication; deterioration of lung function that is, peak expiratory flow, forced expiratory volume in 1 second (FEV1).
6 secondary outcomes
Time to First Asthma Exacerbation Event From Week 0 Through Week 48
Time frame: From Week 0 Through Week 48
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 48
Time frame: Baseline, Week 2, 12, 24, and 48
Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48
Time frame: Baseline, Week 2, 12, 24, and 48
Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48
Time frame: Baseline, Week 48
Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48
Time frame: Baseline, Week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 90 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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-95597528 in people with Asthma, run by Janssen Research & Development, LLC at 19 sites in 5 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Argentina, China, Japan, Israel. 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?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Asthma Exacerbations Through Week 48 (time frame: Up to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.