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Molgramostim for Autoimmune Pulmonary Alveolar Proteinosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Of Arkansas, Little Rock, ARAutoimmune Pulmonary Alveolar ProteinosisMolgramostim - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether a daily inhaled drug can improve aPAP, and will last for 96 weeks total.

Eligible Conditions
  • Autoimmune Pulmonary Alveolar Proteinosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 13 Secondary · Reporting Duration: From screening (6-week) until Follow-up visit (Week 100)

Week 24
Change from baseline in St. Georges Respiratory Questionnaire (SGRQ) Total score to Week 24
Change from baseline in alveolar-arterial oxygen difference (A-aDO2) to Week 24 (Specifically for Japan and South Korea)
Change from baseline in exercise capacity (EC), expressed as peak metabolic equivalents (METs) to Week 24
Change from baseline in percentage (%) predicted diffusing capacity of the lung for carbon monoxide (DLCO) to Week 24
Week 48
Change from baseline in EC, expressed as peak METs to Week 48
Change from baseline in SGRQ Activity from baseline to Week 48
Change from baseline in percentage (%) predicted DLCO to Week 48
Week 24
Changes in Forced expiratory volume in one second (FEV1)
Changes in Forced vital capacity (FVC)
Week 4
Change in QT interval corrected by Fridericia (QTcF)
Week 100
Number of subjects with positive treatment-boosted anti Granulocyte macrophage colony stimulating factor (GM-CSF) antibody titers during 24 weeks' treatment and during 48 weeks' treatment
Number of subjects with serious and non-serious adverse events
Week 24
Change from baseline in SGRQ Activity component score to Week 24
Week 48
Change from baseline in SGRQ Total score to Week 48

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
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2
Amlitelimab
2
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Side Effects for

Double-blind Molgramostim Once Daily
33%Cough
22%Chest pain
15%Nasopharyngitis
13%Headache
11%Dyspnoea
9%Productive cough
7%Weight increased
7%Alveolar proteinosis
4%Pyrexia
4%Respiratory tract infection
4%Back pain
4%Arthralgia
4%Dizziness
2%Laryngeal oedema
2%Respiratory failure
2%Aphasia
2%Pneumonia bacterial
2%Epilepsy
2%Pneumonia
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02702180) in the Double-blind Molgramostim Once Daily ARM group. Side effects include: Cough with 33%, Chest pain with 22%, Nasopharyngitis with 15%, Headache with 13%, Dyspnoea with 11%.

Trial Design

2 Treatment Groups

Molgramostim
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: Molgramostim · Has Placebo Group · Phase 3

Molgramostim
Drug
Experimental Group · 1 Intervention: Molgramostim · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Molgramostim · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molgramostim
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening (6-week) until follow-up visit (week 100)

Who is running the clinical trial?

Savara Inc.Lead Sponsor
8 Previous Clinical Trials
589 Total Patients Enrolled
Bruce Trapnell, ProfPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Bruce Trapnell, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
274 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Anyone can participate regardless of gender.
References

Frequently Asked Questions

For what reasons is Molgramostim typically given to patients?

"While Molgramostim is commonly used to severe infections, it can also be helpful in treating lymphoma, hodgkins, bone marrow transplantation, leukemia, myelocytic, and acute conditions." - Anonymous Online Contributor

Unverified Answer

Could you please share other examples of research using Molgramostim?

"Currently, there are 46 clinical trials underway for Molgramostim with 6 in Phase 3. Most of these research studies are situated in Seattle, Washington; although, there are a total of 1896 locations running Molgramostim clinical trials." - Anonymous Online Contributor

Unverified Answer

Is this test being conducted in numerous locations across Canada?

"There are 24 sites conducting this trial, including University Of Arkansas in Little Rock, University Institute of Cardiology and Respirology of Quebec in Québec, Washington U. in St. Louis in Saint Louis." - Anonymous Online Contributor

Unverified Answer

How many participants are being allowed into this trial?

"In order to properly conduct this trial, we need 160 volunteers that fit the given criteria. Luckily, patients can choose to participate from University Of Arkansas in Little Rock, Arkansas or University Institute of Cardiology and Respirology of Quebec in Québec, Missouri." - Anonymous Online Contributor

Unverified Answer

Has Molgramostim been given the okay by the FDA?

"Molgramostim falls into the category of a Phase 3 trial, which means that there is efficacy data as well as multiple rounds of safety data. Therefore, it received a score of 3 from our team at Power." - Anonymous Online Contributor

Unverified Answer

Are patients being enrolled in this experiment at the moment?

"That is correct. The clinical trial, which began recruiting on May 10th, 2021, is still looking for patients. Last updated on September 22nd, the study needs 160 participants from 24 different medical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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