RECRUITING

Study of Safety and Efficacy of ALT-100mAb in Participants With Moderate/Severe ARDS

Conditions

Acute Respiratory Distress Syndrome (ARDS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2a, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ALT-100mAb in patients with moderate to severe ARDS.

Official Title

PUERTA: A P2A Multi-center, Randomized, Double-blind, Placebo-controlled Study Assessing Safety and Efficacy of the eNAMPT Targeting mAb ALT-100 in Moderate/Severe ARDS/VILI Patients

Quick Facts

Study Start:2023-12-01

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05938036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Hospitalized (or documentation of a plan to admit to the hospital if the patient is in an emergency department) male or non-pregnant female 18 years and above of age at time of enrollment. 2. Participant (or LAR) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form. 3. Participant has a diagnosis of moderate or severe ARDS: 1. Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms. 2. Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS are present). 3. Radiological abnormalities on chest x-ray or computed tomography (CT) scan, ie, bilateral opacities that are not fully explained by effusions, nodules, masses, or lobar/lung collapse. 4. Hypoxemia: 4. Administration of study treatment must be planned to occur within 12 hours of the participant's moderate or severe ARDS diagnosis and within 4 hours of initiation of MV (in the case of individuals requiring immediate MV). 5. Females must be non-pregnant and non-lactating, and either surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device \[IUD\]) from screening until study completion or be post-menopausal for 12 months and above. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at screening for amenorrheic female participants, but the result is not required prior to enrollment. Female participants whose only partner has had a vasectomy, and female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation. 6. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study. 7. Males must be surgically sterile (more than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the Follow-up Period. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible. 8. Male participants must agree to refrain from donating sperm from screening until study completion, including the Follow-up Period, for at least 60 days after the last dose of study treatment. 9. Participant is willing and able to undergo all study procedures and attend the scheduled follow-up visit/s per protocol.	1. Participants with ARDS consequent to COVID-19 infection. 2. Participants requiring immediate MV who have been intubated and on MV for more than 4 hours prior to the planned administration of study treatment on Day 1 3. Moribund participant not expected to survive more 24 hours, in the opinion of the Investigator. 4. Use of extracorporeal life support (eg, ECMO) or, in the opinion of the Investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization. 5. Participant has an underlying clinical condition where, in the opinion of the Investigator, it would be unlikely that the participant would be able to come off ventilation, eg, chronic progressive neuromuscular or respiratory disease. 6. Severe chronic respiratory disease (eg, known chronic obstructive pulmonary disease \[COPD\], pulmonary arterial hypertension \[PAH\], idiopathic pulmonary fibrosis \[IPF\], interstitial lung disease \[ILD\]) requiring supplemental oxygen therapy or MV pre-hospitalization (eg, prior to ARDS diagnosis). 7. Evidence of life-threatening dysrhythmia (eg, ventricular tachycardia, ventricular fibrillation) or cardiac arrest on presentation. 8. Evidence of new or preexisting decompensated heart failure. 9. Absolute neutrophil count lesser than1000 per mm3. 10. Platelet count less than 50000 per mm3. 11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 × ULN. 12. Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 (based on MDRD equation) or requiring hemofiltration or dialysis. 13. Known or suspected active and untreated tuberculosis (TB), HIV, hepatitis B or C infection. 14. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies, fusion proteins, ALT-100 excipients, or a history of drug or other allergy including severe allergic reaction that in the opinion of the Investigator or MM, contraindicates participant participation. 15. Use of any immunomodulatory biologic (eg, anti-IL-1, anti-IL-6R, anti-TNF, inhibitors of complement signaling), cell therapies (eg, mesenchymal stem cells), or small molecule Janus kinase (JAK) inhibitors within the past 7 days or within 5 half-lives (whichever is longer), or planned use of any of these agents from screening until Day 60 of the study, unless approved by the MM. The following will be allowed/ disallowed as indicated: 1. Immunomodulatory biologics for treatment of COVID-19 are excluded and should not be used until Day 60 unless discussed with the MM. Other non-biologic immunomodulators (non-JAK inhibitors), eg, medicines for previous transplantation, or DMARDS, if on a stable dose for 8 weeks and above are permitted. 2. Ongoing chronic (4 weeks and above) use of corticosteroids more than 10 mg/day of prednisone or equivalent at the time of randomization is prohibited. A corticosteroid dose that has been tapered to 10 mg or less within 14 days of randomization is also prohibited. 16. Participants who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization will be excluded from study participation. 17. Participation in a clinical research study evaluating another IP or therapy within 3 months and less than 5 half-lives of the IP prior to the Screening Visit. 18. Any physical examination findings, and/or history of any other illness, concomitant medications, or recent live vaccines that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study. 19. Administered a live vaccine within 14 days prior to IP administration and throughout the duration of the study.

Inclusion Criteria

Exclusion Criteria

1. Hospitalized (or documentation of a plan to admit to the hospital if the patient is in an emergency department) male or non-pregnant female 18 years and above of age at time of enrollment.
2. Participant (or LAR) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
3. Participant has a diagnosis of moderate or severe ARDS:
1. Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms.
2. Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS are present).
3. Radiological abnormalities on chest x-ray or computed tomography (CT) scan, ie, bilateral opacities that are not fully explained by effusions, nodules, masses, or lobar/lung collapse.
4. Hypoxemia:
4. Administration of study treatment must be planned to occur within 12 hours of the participant's moderate or severe ARDS diagnosis and within 4 hours of initiation of MV (in the case of individuals requiring immediate MV).
5. Females must be non-pregnant and non-lactating, and either surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device \[IUD\]) from screening until study completion or be post-menopausal for 12 months and above. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at screening for amenorrheic female participants, but the result is not required prior to enrollment. Female participants whose only partner has had a vasectomy, and female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
6. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
7. Males must be surgically sterile (more than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the Follow-up Period. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible.
8. Male participants must agree to refrain from donating sperm from screening until study completion, including the Follow-up Period, for at least 60 days after the last dose of study treatment.
9. Participant is willing and able to undergo all study procedures and attend the scheduled follow-up visit/s per protocol.

1. Participants with ARDS consequent to COVID-19 infection.
2. Participants requiring immediate MV who have been intubated and on MV for more than 4 hours prior to the planned administration of study treatment on Day 1
3. Moribund participant not expected to survive more 24 hours, in the opinion of the Investigator.
4. Use of extracorporeal life support (eg, ECMO) or, in the opinion of the Investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization.
5. Participant has an underlying clinical condition where, in the opinion of the Investigator, it would be unlikely that the participant would be able to come off ventilation, eg, chronic progressive neuromuscular or respiratory disease.
6. Severe chronic respiratory disease (eg, known chronic obstructive pulmonary disease \[COPD\], pulmonary arterial hypertension \[PAH\], idiopathic pulmonary fibrosis \[IPF\], interstitial lung disease \[ILD\]) requiring supplemental oxygen therapy or MV pre-hospitalization (eg, prior to ARDS diagnosis).
7. Evidence of life-threatening dysrhythmia (eg, ventricular tachycardia, ventricular fibrillation) or cardiac arrest on presentation.
8. Evidence of new or preexisting decompensated heart failure.
9. Absolute neutrophil count lesser than1000 per mm3.
10. Platelet count less than 50000 per mm3.
11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 × ULN.
12. Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 (based on MDRD equation) or requiring hemofiltration or dialysis.
13. Known or suspected active and untreated tuberculosis (TB), HIV, hepatitis B or C infection.
14. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies, fusion proteins, ALT-100 excipients, or a history of drug or other allergy including severe allergic reaction that in the opinion of the Investigator or MM, contraindicates participant participation.
15. Use of any immunomodulatory biologic (eg, anti-IL-1, anti-IL-6R, anti-TNF, inhibitors of complement signaling), cell therapies (eg, mesenchymal stem cells), or small molecule Janus kinase (JAK) inhibitors within the past 7 days or within 5 half-lives (whichever is longer), or planned use of any of these agents from screening until Day 60 of the study, unless approved by the MM. The following will be allowed/ disallowed as indicated:
1. Immunomodulatory biologics for treatment of COVID-19 are excluded and should not be used until Day 60 unless discussed with the MM. Other non-biologic immunomodulators (non-JAK inhibitors), eg, medicines for previous transplantation, or DMARDS, if on a stable dose for 8 weeks and above are permitted.
2. Ongoing chronic (4 weeks and above) use of corticosteroids more than 10 mg/day of prednisone or equivalent at the time of randomization is prohibited. A corticosteroid dose that has been tapered to 10 mg or less within 14 days of randomization is also prohibited.
16. Participants who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization will be excluded from study participation.
17. Participation in a clinical research study evaluating another IP or therapy within 3 months and less than 5 half-lives of the IP prior to the Screening Visit.
18. Any physical examination findings, and/or history of any other illness, concomitant medications, or recent live vaccines that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
19. Administered a live vaccine within 14 days prior to IP administration and throughout the duration of the study.

Contacts and Locations

Study Contact

Stan Miele

CONTACT

(919) 410-0504

stan@aqualungtherapeutics.com

Rebecca Nunn

CONTACT

520-631-8024

becki@aqualungtherapeutics.com

Principal Investigator

Stan Miele

STUDY_DIRECTOR

Aqualung Therapeutics Corp.

Study Locations (Sites)

Banner University of Arizona

Tucson, Arizona, 85721

United States

Collaborators and Investigators

Sponsor: Aqualung Therapeutics Corp.

Stan Miele, STUDY_DIRECTOR, Aqualung Therapeutics Corp.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-12-01

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Acute Respiratory Distress Syndrome (ARDS)