Alpha 1 Antitrypsin DeficiencyPhase 3SWIFT-SCNCT07555483
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
A Phase 3 study testing Alpha-1 15% and Liquid Alpha1-PI in people with Alpha 1 Antitrypsin Deficiency, run by Grifols Therapeutics LLC at 22 sites in 9 countries.
Trial summary
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein. Adults with Alpha-1 Antitrypsin Deficiency will take part. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alpha 1 Antitrypsin Deficiency
- What is being tested?
- Alpha-1 15% and Liquid Alpha1-PI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 22 sitesin 9 countries
- Study dates
- 5 May 2026to 30 Sep 2027
- Phase
- Phase 3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or "at-risk" alleles (patients with "at-risk" alleles must be individually evaluated for eligibility by the Medical Monitor). If the genotype has yet to be documented, a blood draw for genotyping (i.e., allelic discrimination) and phenotyping will be obtained at the Screening Visit.
- Participants may be naïve to alpha1-PI augmentation therapy or may be currently receiving alpha1-PI augmentation therapy or received alpha1-PI augmentation therapy in the past. If the total alpha1-PI serum (alpha-1 antitrypsin [AAT]) level has yet to be documented as in a treatment-naïve patient, a blood draw for total alpha1-PI serum level will be obtained at the Screening Visit. For participants currently receiving alpha1-PI augmentation, a pre-alpha1-PI augmentation AAT level must be documented in the participant's medical history/records.
- All participants must have a documented total alpha1-PI serum level <11 μM (80mg/dL if measured by radial immunodiffusion or 50 mg/dL if measured by nephelometry) which is documented pre-alpha1-PI augmentation for participants receiving AAT augmentation.
- At the Screening Visit, have post-bronchodilator Forced Expiratory Volume in 1 second (FEV₁) ≥25% and <80% predicted of predicted FEV₁/Forced Vital Capacity (FVC) <70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II-III, and some individuals are GOLD stage IV).
- If the participant has received alpha1-PI augmentation therapy of any kind, he/she must be willing to discontinue that treatment at the Week 1 (Baseline) Visit and remain off any kind of alpha1-PI treatment, other than the IPs of this study, while participating in the study.
- Willing and able to provide written informed consent indicating that they understand the purpose of, and procedures required for the study and are willing to participate in it.
Who cannot join
- Have had a moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation during the 4 weeks before the Week 1 (Baseline) Visit.
- Have history of lung or liver transplant or on transplantation waiting list.
- Have any lung surgery during the past 1 year (excluding lung biopsy).
- At screening, have elevated liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) ≥ 2.5 times the upper limit of normal (ULN).
- Have severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease [except for skin cancers other than melanoma], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).
- Females who are pregnant, breastfeeding or, if of child-bearing potential†, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study. †Women of childbearing potential are defined as premenopausal and not surgically sterile, post tubal ligation, nor documented as infertile due to a concurrent medical condition.
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- True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.)
- Have known previous infection with or clinical signs and symptoms consistent with current Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) infection.
- Have smoked during the past 6 months (this includes electronic/vapor cigarettes) or a positive urine cotinine test at the Screening Visit that is due to smoking.
- Received IP in another study within 30 days prior to the Week 1 (Baseline) Visit or received any recombinant human AAT-Fc fusion protein (e.g., INBRX-101) or other extended half-life AAT products within 5 half-lives of the product relative to the Screening Visit date.
- Have history of anaphylaxis or severe systemic response to any plasma-derived alpha1- PI preparation or other blood product(s).
- Use systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 4 weeks prior to the Week 1 (Baseline) Visit (Note: inhaled steroids are not considered systemic steroids). It is recommended to maintain the same dose throughout the study.
- Use systemic or aerosolized antibiotics for a COPD exacerbation within the 4 weeks prior to the Week 1 (Baseline) Visit.
- Have known selective or severe Immunoglobulin A (IgA) deficiency based on prior medical records.
- In the opinion of the Investigator, the participant may have compliance problems or any medical condition that may place them at safety risk with the protocol and the procedures of the protocol, or because of unstable health be unable to come to the study site for in-person clinic visits required by the protocol.
Trial locations and contacts
22 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 9 countries
United States10 sites, 10 recruiting
- Recruiting
GC2501 Study Site 106
Birmingham, Alabama, 35233
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 101
Charleston, South Carolina, 29425
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 104
Cleveland, Ohio, 44195
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 109
Dallas, Texas, 75390
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 103
Gainesville, Florida, 32610
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 100
Los Angelas, California, 90095
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 105
Miami, Florida, 33136
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 102
Phoenix, Arizona, 85032
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 108
Rochester, Minnesota, 55905
Beatriz Garcia Castro, beatriz.garcia@grifols.com
- Not yet recruiting
GC2501 Study Site 107
Scottsdale, Arizona, 85259
Beatriz Garcia Castro, beatriz.garcia@grifols.com
Spain4 sites, 4 recruiting
- Not yet recruiting
GC2501 Study Site 501
Madrid
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 502
San Cristóbal de La Laguna, Santa Cruz de Tenerife
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 503
Seville
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 500
Vigo
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Portugal2 sites, 2 recruiting
- Recruiting
GC2501 Study Site 450
Guimarães
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
- Recruiting
GC2501 Study Site 451
Loures
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Denmark1 site, 1 recruiting
- Recruiting
GC2501 Study Site 150
Vejle
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Germany1 site, 1 recruiting
- Not yet recruiting
GC2501 Study Site 250
Freiburg im Breisgau
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Ireland1 site, 1 recruiting
- Not yet recruiting
GC2501 Study Site 300
Dublin, D09YD60
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Netherlands1 site, 1 recruiting
- Recruiting
GC2501 Study Site 350
Leiden
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Poland1 site, 1 recruiting
- Not yet recruiting
GC2501 Study Site 400
Warsaw
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
Sweden1 site, 1 recruiting
- Recruiting
GC2501 Study Site 550
Malmö
Beatriz Garcia Castro, +(34) 670923669, beatriz.garcia@grifols.com
About this study
Official title: An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.
The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.
- Conditions
- Alpha 1 Antitrypsin Deficiency
- Being tested
- Alpha-1 15%, Liquid Alpha1-PI
- Keywords
- Phase 3, Clinical Trial, Alpha1-Proteinase Inhibitor (Human), Alpha 1-Antitrypsin, Subcutaneous, Intravenous, Pulmonary Emphysema, Emphysema, Pathologic Processes, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases, Respiratory Tract Diseases, Genetic Diseases, Inborn, Subcutaneous Emphysema, Serine Proteinase Inhibitors, Protease Inhibitors, Enzyme Inhibition, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Emphysema, Emphysema, Pathologic Processes, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-1 15%Drug
Alpha1-Proteinase Inhibitor Subcutaneous (Human), 15%
Liquid Alpha1-PIOther
Liquid Alpha1-Proteinase Inhibitor (Human) for Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 (60 mg/kg/week of Liquid Alpha1-PI followed by 90 mg/kg/week of Alpha-1 15%) | Experimental | 8 weeks of IV treatment with 60 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 90 mg/kg/week Alpha-1 15% Receives: Drug: Alpha-1 15%; Other: Liquid Alpha1-PI |
| Treatment Arm 2 (120 mg/kg/week of Liquid Alpha1-PI followed by 180 mg/kg/week of Alpha-1 15%) | Experimental | 8 weeks of IV treatment with 120 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 180 mg/kg/week Alpha-1 15% Receives: Drug: Alpha-1 15%; Other: Liquid Alpha1-PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state AUC of alpha1-PI over the weekly dosing interval (from 0 to 7 days) (AUC0-7 days) in the IV Treatment Period 1 and in the SC Treatment Period 2 for both dose levels
Measured: Week 1 to Week 16
Secondary outcomes (2)
The average value of the steady-state trough alpha1-PI measurements obtained at Weeks 6, 7, 8, and 9 (Period 1)
Measured: Weeks 6, 7, 8 and 9
The average value of the steady-state trough alpha1-PI measurements obtained at Weeks 14, 15, 16, and 17 (Period 2)
Measured: Weeks 14, 15, 16 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha 1 Antitrypsin DeficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555483
- Sponsor's protocol ID
- GC2501
- Other IDs
- 2025-522792-29-00, 2025
- Acronym
- SWIFT-SC
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided