A Phase 3 interventional study of Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis, sponsored by Savara Inc.. Terminated at 13 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Savara Inc. · Phase 3, Interventional, and Treatment
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SAV006-03 is an open-label extension study for participants who had completed the IMPALA study.
At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment.
Participants will be treated with inhaled molgramostim for up to 36 months.
During the trial, whole lung lavage will be applied as rescue therapy.
Savara Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open-label treatment with molgramostim nebulizer solution (300 μg) administered intermittently (repetitive cycles of 7 days of treatment followed by 7 days off-treatment).
Drug: Molgramostim
300 µg inhaled molgramostim in cycles of once daily administration for 7 days, then 7 days off treatment.
Also known as: Recombinant human GM-CSF
Number of Treatment-emergent Adverse Events (TEAEs)
The primary objective of this trial was safety assessed by adverse event (AE) reporting. Definitions and reporting procedures for AEs were done according to current regulatory standards. AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. Treatment-emergent was defined as events occurring on study drug and up to 7 days after last dose of study drug.
Time frame: 139 weeks
Number of Serious TEAEs
Serious TEAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).
Time frame: 139 weeks
Number of Treatment-emergent Adverse Drug Reactions (ADRs)
All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.
Time frame: 139 weeks
Number of TEAEs Leading to Treatment Discontinuation
Time frame: 139 weeks
SAV006-03 was an open-label extension trial for participants who had completed the IMPALA study. Among the 30 clinical sites enrolling participants in IMPALA, 13 sites participated in SAV006-03. First participant was enrolled on 16 April 2018 and last participant completed the study on 14 January 2021.
| Milestone | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Started | 60 |
| Safety analysis set | 59 |
| Completed | 56 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: 1 participant died 24 days after last dose ie outside the definition of treatment-emergent | 1 |
The primary objective of this trial was safety assessed by adverse event (AE) reporting. Definitions and reporting procedures for AEs were done according to current regulatory standards. AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. Treatment-emergent was defined as events occurring on study drug and up to 7 days after last dose of study drug.
| events | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | 165 |
Serious TEAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).
| events | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Number of Serious TEAEs | 8 |
All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.
| events | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Number of Treatment-emergent Adverse Drug Reactions (ADRs) | 3 |
| events | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Number of TEAEs Leading to Treatment Discontinuation | 0 |
Collected over Adverse events (AEs) were collected from the baseline visit up to a follow-up telephone call, which occurred 2 weeks after study completion (maximum duration 139 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Molgramostim Nebulizer Solution (300 μg) | 1/59 (1.7%) | 8/59 (13.6%) | 38/59 (64.4%) |
| Event | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Alveolar proteinosisRespiratory, thoracic and mediastinal disorders | 3/59 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/59 |
| Back painMusculoskeletal and connective tissue disorders | 1/59 |
| HIV infection CDC Group IV subgroup AInfections and infestations | 1/59 |
| LaryngitisInfections and infestations | 1/59 |
| CellulitisInfections and infestations | 1/59 |
| Event | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 7/59 |
| NasopharyngitisInfections and infestations | 7/59 |
| Alveolar proteinosisRespiratory, thoracic and mediastinal disorders | 4/59 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/59 |
| Respiratory tract infectionInfections and infestations | 4/59 |
| COVID-19Infections and infestations | 4/59 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/59 |
| FatigueGeneral disorders | 3/59 |
| BronchitisInfections and infestations | 3/59 |
| PneumoniaInfections and infestations | 3/59 |
| Age, Categorical(Participants) | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 55 |
| >=65 years | 5 |
| Age, Continuous(years) | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Mean | 46.8 ± 13.5 |
| Sex: Female, Male(Participants) | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Female | 24 |
| Male | 36 |
| Race (NIH/OMB)(Participants) | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 54 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Molgramostim Nebulizer Solution (300 μg) |
|---|---|
| Greece | 4 |
| Netherlands | 6 |
| Turkey | 7 |
| Denmark | 3 |
| United Kingdom | 4 |
| Italy | 9 |
| Israel | 4 |
| France | 4 |
| Germany | 12 |
| Russia | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Jan 2021, 32 months.
Results were first posted in Jul 2024, 3 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Molgramostim
Pulmonary Alveolar Proteinosis, Acquired
Savara Inc.