Testing CE1226 doses to slow lung disease in adults with alpha-1 antitrypsin deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, parallel-group, double-blind, randomized Phase 4 trial evaluating two active CE1226 doses for their ability to reduce the rate of annual lung density loss in adults with AAT deficiency-related emphysema. Participants are randomized to receive either one of two active dose levels or a comparator dose, with blinding maintained for investigators and participants. The study follows participants for three years to assess changes in lung density by imaging, aiming to identify an optimal dosing strategy to slow disease progression. Eligible adults are 18–65 with PiZZ, PiZ(null), or Pi(null/null) genotypes and low serum AAT levels, without recent pulmonary exacerbations or prior AAT gene therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age greater than or equal to (\>=) 18 and less than or equal to (\<=) 65 years at the time of providing written informed consent.
* Confirmed diagnosis of emphysema related to AATD with either the PiZZ, PiZ(null), or Pi(null/null) genotype with documented serum AAT levels less than (\<) 11 micrometer (μM) (or \< 50 mg/dL \[milligram/deciliter\]) at any time before the first administration of CE1226 on Day 1 (Baseline).

Exclusion Criteria:

* Participants should not have acute illness or pulmonary exacerbation within 6 weeks before the first administration of CE1226 on Day 1 (Baseline).
* Participants should not have previously received gene therapy for AATD at any point.
* Participants with liver disease secondary to AATD.

Where it's running

• Aalborg Universitetshospital, Syd
  Aalborg, Denmark Recruiting
• Sygehus Lillebælt, Vejle
  Vejle, Denmark Recruiting

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.