Phase1/2A to evaluate the effects of ARO-MMP7 in healthy subject and patients with IPF
Research type
Research Study
Full title
A PHASE 1/2A STUDY EVALUATING THE EFFECTS OF ARO-MMP7 INHALATION SOLUTION IN HEALTHY SUBJECTS AND PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
IRAS ID
1008087
Contact name
Jesse Ho
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Eudract number
2023-504964-41
Clinicaltrials.gov Identifier
Research summary
Summary of Research
This is a Phase 1/2a, randomized, double-blind, placebo-controlled study in NHVs and patients with IPF. ARO-MMP7 is intended for use in patients with IPF. However, because these patients may have baseline decreased lung function and are frequently on multiple concomitant medications, this study will first evaluate dose levels in an NHV population to generate a baseline understanding of safety in a population with normal airway physiology and limited concomitant medication use prior to evaluating dose levels in patients with IPF. Additionally, NHV cohorts will generate an initial understanding of dose-response, using MMP7 protein concentration as a biomarker of PD effect. For all cohorts, participants who have signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form and met all the protocol eligibility criteria during Screening will be randomized to receive ARO-MMP7 or placebo.
The NHV population (different cohorts) described in the Protocol will take part in Countries out of Europe (New Zealand) and just the cohorts referring to patients with IPF, described in the Protocol, will take part in the European portion of the trial including UK.Summary of Results
Why was this study done?
This study was done to learn about an experimental drug called ARO-MMP7 inhalation solution (ARO-MMP7) as a possible treatment for idiopathic pulmonary fibrosis (IPF). People with IPF have scarring in their lungs, which makes it hard to breathe.What was the main goal of the study?
The main goal of this study was to learn about the possible side effects of different doses of ARO-MMP7.Who took part?
There were 105 participants in this study. This included 82 healthy volunteers (48 females, 34 males) and 23 people with IPF (3 females, 20 males). Everyone was between 18 and 84 years old when they joined the study. The participants were from New Zealand, the United Kingdom, South Korea, Spain, and Denmark.What treatments did the participants receive?
The participants received 1 of 2 treatments: ARO-MMP7 or a placebo (an identical-looking treatment with no active ingredients).
During the study, none of the participants, doctors, or other study staff knew which treatment each participant received. Researchers used a computer program to randomly choose the treatment each participant received.What happened during the study?
This study was done in 3 parts.
In Part 1, researchers studied the effects of 5 different dose levels of ARO-MMP7 in groups of healthy volunteers. Everyone in Part 1 received their assigned treatment once.
In Part 2, researchers again studied the effects of 5 different dose levels of ARO-MMP7 in groups of healthy volunteers. Everyone in Part 2 received their assigned treatment 3 times, with 2 weeks between doses.
In Part 3, researchers studied the effects of 3 different dose levels of ARO-MMP7 in people with IPF. Everyone in Part 3 received their assigned treatment 3 times, with 2 weeks between doses.
The participants were in the study for about 4 months. The study started in November 2022 and ended in September 2025.What were the results?
The potential side effects seen in this study are called adverse reactions. These are any new or worsening medical issues that the participants had during the study that doctors thought might be related to their study treatment.
Some adverse reactions are considered “serious”. Examples of serious adverse reactions are those that are life threatening, cause long-term problems, or need hospital care for treatment. None of the participants in this study had a serious adverse reaction.
Non-serious adverse reactions happened to:
• 9 of 34 healthy volunteers (27%) who received ARO-MMP7 in Part 1
• 6 of 25 healthy volunteers (24%) who received ARO-MMP7 in Part 2
• 3 of 17 people with IPF (18%) who received ARO-MMP7 in Part 3
• 5 of 29 participants (17%) who received the placebo in Part 1 (2 participants), Part 2 (2 participants), or Part 3 (1 participant)
The most common adverse reactions were headache and cough. These were the only adverse reactions that affected more than 1 participant in any study part.
Headache was reported as an adverse reaction in:
• 3 of 34 healthy volunteers (9%) who received ARO-MMP7 in Part 1
• 1 of 25 healthy volunteers (4%) who received ARO-MMP7 in Part 2
• None of the 17 people with IPF who received ARO-MMP7 in Part 3
• 2 of 29 participants (7%) who received the placebo in any study part (both of these participants were in Part 1)
Cough was reported as an adverse reaction in:
• 2 of 34 healthy volunteers (6%) who received ARO-MMP7 in Part 1
• 2 of 25 healthy volunteers (8%) who received ARO-MMP7 in Part 2
• 2 of 17 people with IPF (12%) who received ARO-MMP7 in Part 3
• 1 of 29 participants (3%) who received the placebo in any study part (this participant was in Part 2)
None of the participants stopped taking their study treatment because of an adverse reaction.How has this study helped?
The results of this study helped researchers begin to learn about ARO-MMP7 as a possible treatment for people with IPF. This summary only shows the results from this study. Other studies might have different results. Additional clinical studies with ARO-MMP7 are being considered.Where can I learn more about this study?
• https://euclinicaltrials.eu/ (On this website, click “Search clinical trials”. Type the study’s EU Clinical Trial Number [2023-504964-41-00] into the top search box, scroll down, and click “Search”. This is a technical summary of the study results.)
• http://www.clinicaltrials.gov (On this website, type the study’s National Clinical Trial Number [NCT05537025] into one of the search boxes and hit “Enter”. This is a technical summary of the study results.)
Full study title: A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients with Idiopathic Pulmonary Fibrosis
Study protocol number: AROMMP7-1001
Contact information for the study sponsor: Arrowhead Pharmaceuticals, Inc. / Address: 177 East Colorado Blvd., Suite 700 Pasadena, CA 91105 USA / Phone: +1 626-304-3400REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0160
Date of REC Opinion
20 Oct 2023
REC opinion
Further Information Favourable Opinion