Phase 2 Cystic Fibrosis Trial, Recruiting NCT07048262 Sponsor: CSL Behring Condition: Cystic Fibrosis
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Phase 2 Cystic Fibrosis Trial, Recruiting

NCT07048262
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged between 18 and 85 years old.
  • People who have been diagnosed with non-cystic fibrosis bronchiectasis (a lung condition where the airways are permanently widened), confirmed by a chest CT scan reviewed by a radiologist — a scan from within the past 12 months is acceptable, or one will be arranged during the screening period if needed.
  • People who have had at least 2 lung infection flare-ups in the past year that required antibiotic treatment (by mouth or through a drip), OR at least 1 such flare-up plus a score above 40 on a specific respiratory symptom questionnaire given during screening.
  • People already taking certain long-term lung medications (such as macrolide antibiotics or DPP-1 inhibitors) may still be eligible, provided at least 1 flare-up occurred while they had been on a stable dose of that medication for 3 months or more.
  • People whose lungs are functioning above a certain level, based on a breathing test done during screening — specifically, a post-bronchodilator FEV1 above 35% of the predicted normal value and at least 1 litre in volume (confirm with trial site if unsure what this means for a specific situation).

Who may not be able to join:

  • People who have previously experienced airway spasms or breathing problems in response to inhaled treatments, including inhaled antibiotics.
  • People with a known or suspected allergy or severe reaction to the study drug, any of its ingredients, or to immunoglobulin-based medicines.
  • People whose primary lung diagnosis is a condition other than non-cystic fibrosis bronchiectasis, such as COPD, asthma, or diffuse panbronchiolitis, as determined by the treating doctor.
  • People who have had a lung infection flare-up requiring antibiotic treatment within the 4 weeks before the study baseline visit.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, CSL Behring

Phone: +1 610-878-4697

Australian sites

The Prince Charles Hospital, Queensland,
Westmead Hospital, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
CSL Behring
Registry
ClinicalTrials.gov
Start date
3 September 2025
Est. completion
28 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇯🇵 Japan

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to first (TTF) Exacerbation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov