Bronchiectasis With Pseudomonas Aeruginosa ColonizationPhase 2CLEARNCT07088926
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
A Phase 2 study testing AZD0292 in people with Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by AstraZeneca at 186 sites in 25 countries.
Trial summary
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Bronchiectasis With Pseudomonas Aeruginosa Colonization
- What is being tested?
- AZD0292
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 435 participants
- Where
- 186 sitesin 25 countries
- Study dates
- 6 Nov 2025to 14 Jun 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
- Weight ≥ 35 kg
- Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
- Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
- Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
Show all 9Show fewer
- Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
- Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study. Participants who experience an exacerbation during the screening period and receive antibiotic therapy remain eligible for the study if the presence of culture-positive PsA is confirmed prior to randomization.
- Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Who cannot join
- Primary lung diagnosis other than bronchiectasis
- Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active tuberculosis or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
- Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
- Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
- Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
- AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)
Show all 12Show fewer
- History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
- Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
- Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
- Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
- Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening
- Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration
Trial locations and contacts
186 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
186 sites in 25 countries
United States25 sites, 18 recruiting
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Withdrawn
Research Site
Austin, Texas, 78705
- Recruiting
Research Site
Charleston, South Carolina, 29425
- Not yet recruiting
Research Site
Denver, Colorado, 80206
- Withdrawn
Research Site
Detroit, Michigan, 48202
- Withdrawn
Research Site
DuBois, Pennsylvania, 15801
- Recruiting
Research Site
Jacksonville, Florida, 32209
- Recruiting
Research Site
Kansas City, Kansas, 66160
- Recruiting
Research Site
Mansfield, Texas, 76063
- Terminated
Research Site
Miami Lakes, Florida, 33014
- Recruiting
Research Site
Naples, Florida, 34102
- Recruiting
Research Site
New Bern, North Carolina, 28562
- Recruiting
Research Site
New York, New York, 10016
- Recruiting
Research Site
Orange, California, 92868
- Recruiting
Research Site
Ormond Beach, Florida, 32174
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Research Site
Plantation, Florida, 33324
- Recruiting
Research Site
Rincon, Georgia, 31326
- Withdrawn
Research Site
Rochester, Minnesota, 55905
- Withdrawn
Research Site
Rock Hill, South Carolina, 29732
- Recruiting
Research Site
San Francisco, California, 94143
- Recruiting
Research Site
St Louis, Missouri, 63130
- Withdrawn
Research Site
Tulsa, Oklahoma, 74133
- Recruiting
Research Site
Washington D.C., District of Columbia, 20007
- Not yet recruiting
Research Site
Winston-Salem, North Carolina, 27104
Japan14 sites, 14 recruiting
- Not yet recruiting
Research Site
Bunkyō City, 113-8655
- Recruiting
Research Site
Gifu, 500-8717
- Recruiting
Research Site
Hiratsuka-shi, 254-8502
- Recruiting
Research Site
Kamogawa-shi, 296-0041
- Recruiting
Research Site
Kiyose-shi, 204-8522
- Recruiting
Research Site
Kiyose-shi, 204-8585
- Recruiting
Research Site
Kurashiki-shi, 710-8602
- Not yet recruiting
Research Site
Meguro-ku, 153-0061
- Recruiting
Research Site
Miyazaki, 889-1692
- Recruiting
Research Site
Nagasaki, 852-8501
- Recruiting
Research Site
Ogi, 845-0032
- Recruiting
Research Site
Shinjuku-ku, 160-8582
- Recruiting
Research Site
Shinjuku-ku, 162-8655
- Recruiting
Research Site
Urayasu-shi, 279-0021
Brazil11 sites, 9 recruiting
- Recruiting
Research Site
Blumenau, 89030-101
- Recruiting
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Campinas, 13060-080
- Recruiting
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Curitiba, 80030-110
- Recruiting
Research Site
Curitiba, 80230-130
- Recruiting
Research Site
Porto Alegre, 9061-000
- Recruiting
Research Site
Porto Alegre, 90630-165
- Withdrawn
Research Site
Porto Alegre, 91350-200
- Withdrawn
Research Site
Salvador, 40050-410
- Recruiting
Research Site
São José dos Campos, 12230-001
- Recruiting
Research Site
São Paulo, 05.403-010
- Recruiting
Research Site
São Paulo, 05403-000
Germany9 sites, 8 recruiting
- Recruiting
Research Site
Berlin, 10117
- Withdrawn
Research Site
Darmstadt, 64283
- Recruiting
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Essen, 45239
- Recruiting
Research Site
Frankfurt, 60596
- Recruiting
Research Site
Halle, 06108
- Recruiting
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Hanover, 30625
- Recruiting
Research Site
Konstanz, 78464
- Recruiting
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München, 80336
- Recruiting
Research Site
München-Pasing, 81241
Peru9 sites, 6 recruiting
- Withdrawn
Research Site
Bellavista, CALLAO 2
- Not yet recruiting
Research Site
Callao, Bellavista
- Recruiting
Research Site
Lima, 15023
- Recruiting
Research Site
Lima, 15036
- Recruiting
Research Site
Lima, 15038
- Not yet recruiting
Research Site
Lima, 15082
- Withdrawn
Research Site
Lima, 15088
- Recruiting
Research Site
Lima, LIMA 1
- Withdrawn
Research Site
Lima, LIMA 29
South Korea9 sites, 9 recruiting
- Recruiting
Research Site
Anyang-si, 14068
- Recruiting
Research Site
Cheongju-si, 28644
- Recruiting
Research Site
Daegu, 42415
- Recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 04763
- Recruiting
Research Site
Seoul, 05030
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 07441
- Recruiting
Research Site
Ulsan, 44033
United Kingdom9 sites, 9 recruiting
- Recruiting
Research Site
Belfast, BT9 7AB
- Recruiting
Research Site
Birmingham, B9 5SS
- Recruiting
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Brighton, BN2 1ES
- Recruiting
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Cambridge, CB2 0AY
- Recruiting
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Dundee, DD1 9SY
- Recruiting
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Edinburgh, EH16 4SA
- Recruiting
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Exeter, EX2 5DW
- Recruiting
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Liverpool, L14 3PE
- Recruiting
Research Site
Manchester, M23 9LT
France8 sites, 8 recruiting
- Recruiting
Research Site
Brest, 29200
- Recruiting
Research Site
Créteil, 94010
- Recruiting
Research Site
Marseille, 13915
- Recruiting
Research Site
Montpellier, 34295
- Recruiting
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Paris, 75014
- Recruiting
Research Site
Pessac, 33604
- Recruiting
Research Site
Strasbourg, 67091
- Recruiting
Research Site
Toulouse, 31100
Greece8 sites, 8 recruiting
- Recruiting
Research Site
Athens, 11527
- Recruiting
Research Site
Athens, 12462
- Recruiting
Research Site
Athens, 15126
- Recruiting
Research Site
Athens, 17562
- Recruiting
Research Site
Ioannina, 45500
- Recruiting
Research Site
Larissa, 41110
- Recruiting
Research Site
Pátrai, 26500
- Recruiting
Research Site
Thessaloniki, 57010
Spain8 sites, 8 recruiting
- Recruiting
Research Site
Barcelona, 08003
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Benalmádena, 29631
- Recruiting
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Madrid, 28040
- Recruiting
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Madrid, 28046
- Recruiting
Research Site
Mérida, 06800
- Recruiting
Research Site
Patraix, 46017
- Recruiting
Research Site
Valencia, 46009
Canada7 sites, 6 recruiting
- Recruiting
Research Site
Ajax, Ontario, L1S 2J5
- Recruiting
Research Site
Calgary, Alberta, T2N4Z6
- Recruiting
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Québec, Quebec, G1V 4G5
- Recruiting
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4
- Recruiting
Research Site
Stoney Creek, Ontario, L8G 2V6
- Withdrawn
Research Site
Trois-Rivières, Quebec, G8T 7A1
- Recruiting
Research Site
Vancouver, British Columbia, V5Z 1M9
Italy7 sites, 7 recruiting
- Recruiting
Research Site
Milan, 20122
- Recruiting
Research Site
Palermo, 90127
- Recruiting
Research Site
Pavia, 27100
- Recruiting
Research Site
Perugia, 06129
- Recruiting
Research Site
Roma, 00163
- Recruiting
Research Site
Rozzano, 20089
- Recruiting
Research Site
Torrette, 60126
Taiwan7 sites, 7 recruiting
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taipei, 0116
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 110
- Recruiting
Research Site
Taoyuan, 333
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Research Site
Adana, 1330
- Recruiting
Research Site
Ankara, 6340
- Recruiting
Research Site
Diyarbakır, 21280
- Recruiting
Research Site
Istanbul, 34098
- Recruiting
Research Site
Istanbul, 34890
- Recruiting
Research Site
Mersin, 33343
- Recruiting
Research Site
Zeytinburnu, 34020
Israel6 sites, 6 recruiting
- Recruiting
Research Site
Ashkelon, 7830604
- Recruiting
Research Site
Haifa, 34362
- Recruiting
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Jerusalem, 00000
- Recruiting
Research Site
Jerusalem, 91031
- Recruiting
Research Site
Ramat Gan, 52621
- Recruiting
Research Site
Tel Aviv, 6423906
Vietnam6 sites, 6 recruiting
- Not yet recruiting
Research Site
Can Tho, 900000
- Recruiting
Research Site
Hà Nội, 100000
- Recruiting
Research Site
Haiphong, 180000
- Recruiting
Research Site
Hanoi, 100000
- Recruiting
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Huế, 530000
Chile5 sites, 5 recruiting
- Recruiting
Research Site
Concepción, 4070196
- Recruiting
Research Site
Santiago, 8150000
- Recruiting
Research Site
Santiago, 8380453
- Recruiting
Research Site
Talca, 3481349
- Recruiting
Research Site
Viña del Mar, 2540364
Denmark5 sites, 4 recruiting
- Recruiting
Research Site
Aalborg, 9000
- Withdrawn
Research Site
Aarhus N, 8200
- Recruiting
Research Site
Hvidovre, 2650
- Recruiting
Research Site
Odense C, 5000
- Recruiting
Research Site
Roskilde, 4000
Thailand5 sites, 5 recruiting
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Muang, 40002
- Recruiting
Research Site
Muang, 50200
- Recruiting
Research Site
Nonthaburi, 11000
- Recruiting
Research Site
Pathum Thani, 12120
Argentina4 sites, 4 recruiting
- Recruiting
Research Site
Ciudad de Buenos Aires, C1180AAX
- Recruiting
Research Site
Florida, B1602DQD
- Recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
San Miguel de Tucumán, 4000
Belgium4 sites, 4 recruiting
- Recruiting
Research Site
Ghent, 9000
- Recruiting
Research Site
Leuven, 3000
- Recruiting
Research Site
Liège, 4000
- Recruiting
Research Site
Sint-Niklaas, 9100
Philippines4 sites, 4 recruiting
- Recruiting
Research Site
Iloilo City, 5000
- Recruiting
Research Site
Manila, 1000
- Recruiting
Research Site
Quezon City, 1100
- Recruiting
Research Site
Tondo, 1012
Australia3 sites, 3 recruiting
- Recruiting
Research Site
Birtinya, 4575
- Recruiting
Research Site
Macquarie University, 2109
- Recruiting
Research Site
South Brisbane, 4101
Malaysia3 sites, 3 recruiting
- Recruiting
Research Site
Bandar Puncak Alam, 42300
- Recruiting
Research Site
Kuala Lumpur, 59100
- Recruiting
Research Site
Sibu, 96000
Netherlands3 sites, 2 recruiting
- Recruiting
Research Site
Amsterdam, 1081 HV
- Recruiting
Research Site
Rotterdam, 3015 GD
- Withdrawn
Research Site
Zutphens, 7207 AE
About this study
Official title: A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Read the detailed description
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older.
The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.
- Being tested
- AZD0292, Placebo
- Keywords
- Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0292Biological
AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
PlaceboOther
Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
| Study group | Role | What they receive |
|---|---|---|
| High-dose | Experimental | High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. Receives: Biological: AZD0292 |
| Low-dose | Experimental | Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. Receives: Biological: AZD0292 |
| Placebo | Placebo comparator | Placebo administered starting on Day 1, subsequent administrations per schedule of assessments. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of exacerbations over a variable follow-up time
To evaluate the effect of AZD0292 compared to placebo on the rate of moderate or severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA.
Measured: Min 28 weeks, max 52 weeks
Secondary outcomes (7)
Annualized rate of severe exacerbations over a variable follow-up time
To evaluate the effect of AZD0292 compared to placebo on severe exacerbations in participants with NCFBE and chronic colonization with PsA
Measured: Min 28 weeks, max 52 weeks
Change from baseline in QOL-B-RSS
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period
Measured: Over the observation period (Week 0 to Final Dose+4 weeks)
Change from baseline in SGRQ score
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.
Measured: Over the observation period (Week 0 to Final Dose +4 weeks)
Time to first moderate or severe exacerbation
To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
Measured: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
Measured: At specified timepoints between Week 0 and Final Dose+12 weeks
Incidence of ADA and ADA titers to AZD0292
To evaluate the immunogenicity of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
Measured: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of AEs, SAEs, AESIs and MAAEs
To assess the safety of AZD0292 compared with placebo in participants with bronchiectasis and chronic colonization with PsA
Measured: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start6 Nov 2025
- Primary completion9 Dec 2027 (estimated)
- Study completion14 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis With Pseudomonas Aeruginosa ColonizationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- D7700C00003 is a multicenter, randomized, Phase IIb, double-blind, placebo-controlled, parallel, multidose study to evaluate the efficacy, safety, and PK of AZD0292 compared with placebo in participants with bronchiectasis and chronic PsA colonization. The study will enroll up to 435 bronchiectasis participants.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 435 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088926
- Sponsor's protocol ID
- D7700C00003
- Acronym
- CLEAR
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Araujo D, Shteinberg M, Aliberti S, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Stone G, Trautmann M, Davis A, Dimakou K, Polverino E, De Soyza A, McDonnell MJ, Chalmers JD. The independent contribution of Pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis. Eur Respir J. 2018 Jan 31;51(2):1701953. doi: 10.1183/13993003.01953-2017. Print 2018 Feb.
PubMed 29386336Artaraz A, Crichton ML, Finch S, Abo-Leyah H, Goeminne P, Aliberti S, Fardon T, Chalmers JD. Development and initial validation of the bronchiectasis exacerbation and symptom tool (BEST). Respir Res. 2020 Jan 13;21(1):18. doi: 10.1186/s12931-019-1272-y.
PubMed 31931782Bellelli G, Chalmers JD, Sotgiu G, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Skrbic D, Lombi A, Pane F, Obradovic D, Fardon TC, Rutherford RM, Pesci A, Aliberti S. Characterization of bronchiectasis in the elderly. Respir Med. 2016 Oct;119:13-19. doi: 10.1016/j.rmed.2016.08.008. Epub 2016 Aug 17.
PubMed 27692133CFFPR 2023 Cystic Fibrosis Foundation Patient Registry. Bethesda, MD. 2023 Annual Data Report. Available at https://www.cff.org/media/34491/download.
Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
PubMed 24328736Chalmers JD, Aliberti S, Blasi F. Management of bronchiectasis in adults. Eur Respir J. 2015 May;45(5):1446-62. doi: 10.1183/09031936.00119114. Epub 2015 Mar 18.
PubMed 25792635Chalmers JD, Chang AB, Chotirmall SH, Dhar R, McShane PJ. Bronchiectasis. Nat Rev Dis Primers. 2018 Nov 15;4(1):45. doi: 10.1038/s41572-018-0042-3.
PubMed 30442957Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
PubMed 29357265Chalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018 Sep;6(9):715-726. doi: 10.1016/S2213-2600(18)30053-5. Epub 2018 Feb 23.
PubMed 29478908Chawla K, Vishwanath S, Manu MK, Lazer B. Influence of pseudomonas aeruginosa on exacerbation in patients with bronchiectasis. J Glob Infect Dis. 2015 Jan-Mar;7(1):18-22. doi: 10.4103/0974-777X.150885.
PubMed 25722615Choate R, Aksamit TR, Mannino D, Addrizzo-Harris D, Barker A, Basavaraj A, Daley CL, Daniels MLA, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, McShane PJ, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL, Stone G. Pseudomonas aeruginosa associated with severity of non-cystic fibrosis bronchiectasis measured by the modified bronchiectasis severity score (BSI) and the FACED: The US bronchiectasis and NTM Research Registry (BRR) study. Respir Med. 2021 Feb;177:106285. doi: 10.1016/j.rmed.2020.106285. Epub 2020 Dec 24.
PubMed 33401148Choi H, Xu JF, Chotirmall SH, Chalmers JD, Morgan LC, Dhar R. Bronchiectasis in Asia: a review of current status and challenges. Eur Respir Rev. 2024 Sep 25;33(173):240096. doi: 10.1183/16000617.0096-2024. Print 2024 Jul.
PubMed 39322263Ciofu O, Tolker-Nielsen T. Tolerance and Resistance of Pseudomonas aeruginosa Biofilms to Antimicrobial Agents-How P. aeruginosa Can Escape Antibiotics. Front Microbiol. 2019 May 3;10:913. doi: 10.3389/fmicb.2019.00913. eCollection 2019.
PubMed 31130925DiGiandomenico A, Warrener P, Hamilton M, Guillard S, Ravn P, Minter R, Camara MM, Venkatraman V, Macgill RS, Lin J, Wang Q, Keller AE, Bonnell JC, Tomich M, Jermutus L, McCarthy MP, Melnick DA, Suzich JA, Stover CK. Identification of broadly protective human antibodies to Pseudomonas aeruginosa exopolysaccharide Psl by phenotypic screening. J Exp Med. 2012 Jul 2;209(7):1273-87. doi: 10.1084/jem.20120033. Epub 2012 Jun 25.
PubMed 22734046Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatr Pulmonol. 2002 Aug;34(2):91-100. doi: 10.1002/ppul.10127.
PubMed 12112774
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
- ClinicalTrials.gov ID
- NCT07088926
- Acronym / sponsor ID
- CLEAR / D7700C00003
- Keywords
- Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 14 Jun 2028 (estimated)
- First posted
- 28 Jul 2025 (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.
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Detailed description
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older.
The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- D7700C00003 is a multicenter, randomized, Phase IIb, double-blind, placebo-controlled, parallel, multidose study to evaluate the efficacy, safety, and PK of AZD0292 compared with placebo in participants with bronchiectasis and chronic PsA colonization. The study will enroll up to 435 bronchiectasis participants.
| Arm | Type | Receives |
|---|---|---|
| High-dose | Experimental | Biological: AZD0292High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. |
| Low-dose | Experimental | Biological: AZD0292Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered starting on Day 1, subsequent administrations per schedule of assessments. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
- Weight ≥ 35 kg
- Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
- Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
Key exclusion criteria (12 listed)
- Primary lung diagnosis other than bronchiectasis
- Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active tuberculosis or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
- Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
- Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
- Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
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 |
|---|---|---|
| AZD0292AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments. | Biological | High-dose, Low-dose |
| PlaceboPlacebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments. | Other | Placebo |
Primary outcome
Annualized rate of exacerbations over a variable follow-up time
Time frame: Min 28 weeks, max 52 weeks
To evaluate the effect of AZD0292 compared to placebo on the rate of moderate or severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA.
7 secondary outcomes
Annualized rate of severe exacerbations over a variable follow-up time
Time frame: Min 28 weeks, max 52 weeks
Change from baseline in QOL-B-RSS
Time frame: Over the observation period (Week 0 to Final Dose+4 weeks)
Change from baseline in SGRQ score
Time frame: Over the observation period (Week 0 to Final Dose +4 weeks)
Time to first moderate or severe exacerbation
Time frame: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
Time frame: At specified timepoints between Week 0 and Final Dose+12 weeks
Incidence of ADA and ADA titers to AZD0292
Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of AEs, SAEs, AESIs and MAAEs
Time frame: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 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 2 Oct 2026.
- Background: PubMed 29386336Araujo D, Shteinberg M, Aliberti S, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Stone G, Trautmann M, Davis A, Dimakou K, Polverino E, De Soyza A, McDonnell MJ, Chalmers JD. The independent contribution of Pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis. Eur Respir J. 2018 Jan 31;51(2):1701953. doi: 10.1183/13993003.01953-2017. Print 2018 Feb.
- Background: PubMed 31931782Artaraz A, Crichton ML, Finch S, Abo-Leyah H, Goeminne P, Aliberti S, Fardon T, Chalmers JD. Development and initial validation of the bronchiectasis exacerbation and symptom tool (BEST). Respir Res. 2020 Jan 13;21(1):18. doi: 10.1186/s12931-019-1272-y.
- Background: PubMed 27692133Bellelli G, Chalmers JD, Sotgiu G, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Skrbic D, Lombi A, Pane F, Obradovic D, Fardon TC, Rutherford RM, Pesci A, Aliberti S. Characterization of bronchiectasis in the elderly. Respir Med. 2016 Oct;119:13-19. doi: 10.1016/j.rmed.2016.08.008. Epub 2016 Aug 17.
- BackgroundCFFPR 2023 Cystic Fibrosis Foundation Patient Registry. Bethesda, MD. 2023 Annual Data Report. Available at https://www.cff.org/media/34491/download.
- Background: PubMed 24328736Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
- Background: PubMed 25792635Chalmers JD, Aliberti S, Blasi F. Management of bronchiectasis in adults. Eur Respir J. 2015 May;45(5):1446-62. doi: 10.1183/09031936.00119114. Epub 2015 Mar 18.
- Background: PubMed 30442957Chalmers JD, Chang AB, Chotirmall SH, Dhar R, McShane PJ. Bronchiectasis. Nat Rev Dis Primers. 2018 Nov 15;4(1):45. doi: 10.1038/s41572-018-0042-3.
- Background: PubMed 29357265Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
- Background: PubMed 29478908Chalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018 Sep;6(9):715-726. doi: 10.1016/S2213-2600(18)30053-5. Epub 2018 Feb 23.
- Background: PubMed 25722615Chawla K, Vishwanath S, Manu MK, Lazer B. Influence of pseudomonas aeruginosa on exacerbation in patients with bronchiectasis. J Glob Infect Dis. 2015 Jan-Mar;7(1):18-22. doi: 10.4103/0974-777X.150885.
- Background: PubMed 33401148Choate R, Aksamit TR, Mannino D, Addrizzo-Harris D, Barker A, Basavaraj A, Daley CL, Daniels MLA, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, McShane PJ, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL, Stone G. Pseudomonas aeruginosa associated with severity of non-cystic fibrosis bronchiectasis measured by the modified bronchiectasis severity score (BSI) and the FACED: The US bronchiectasis and NTM Research Registry (BRR) study. Respir Med. 2021 Feb;177:106285. doi: 10.1016/j.rmed.2020.106285. Epub 2020 Dec 24.
- Background: PubMed 39322263Choi H, Xu JF, Chotirmall SH, Chalmers JD, Morgan LC, Dhar R. Bronchiectasis in Asia: a review of current status and challenges. Eur Respir Rev. 2024 Sep 25;33(173):240096. doi: 10.1183/16000617.0096-2024. Print 2024 Jul.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Clinical Study Information Center contact
186 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0292 in people with Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by AstraZeneca at 186 sites in 25 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 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 186 sites in United States, Japan, Brazil, Germany, Peru and 20 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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of exacerbations over a variable follow-up time (time frame: Min 28 weeks, max 52 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 NCT07088926, which also lists 40 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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.