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WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorMediar Therapeutics

About this trial

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.

Able to understand the study and provide signed, written informed consent.

Able to read and understand the language of the informed consent and other study-related materials.

Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.

Disqualifiers

Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.

Forced expiratory volume in 1 second (FEV1)/FVC ratio of <0.7 at Screening.

Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.

Expected to receive a lung transplant within the study duration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MTX-463

    Biological/Vaccine

    MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.

  • Placebo

    Other intervention

    Placebo

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: MTX-463Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)

Change from Baseline to Week 24 in Forced Vital Capacity (FVC)

Time frame
24 Weeks

Secondary outcomes

1

To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events

Incidence of treatment-emergent adverse events (TEAEs) from Baseline until Week 28 in each group

Time frame
28 Weeks
2

To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment related adverse events

Incidence of treatment related adverse events from Baseline until Week 28 in each group

Time frame
28 Weeks
3

To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of serious treatment emergent adverse events

Incidence of serious treatment emergent adverse events from Baseline until Week 28 in each group

Time frame
28 Weeks
4

To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of severe treatment emergent adverse events

Incidence of severe treatment emergent adverse events from Baseline until week 28 in each group

Time frame
28 Weeks

Other outcomes

1

To assess the development of antidrug antibodies (ADA) against MTX-463

Samples will be collected from Baseline until Week 28 to assess the rate at which antibodies develop to the study drug

Time frame
28 Weeks
2

To assess the effect of MTX-463 on the change from Baseline in FVC in participants on concomitant pirfenidone, nintedanib, or nerandomilast

The change from Baseline to week 24 in the mean FVC (in ML) will be measured in each group in the subset of participants who enter the study on background IPF medications, pirfenidone, nintedanib, or nerandomilast

Time frame
24 Weeks
3

To assess the effect of MTX-463 on the change from Baseline in FVC in participants not on concomitant pirfenidone, nintedanib, or nerandomilast

The change from baseline to week 24 in the mean FVC (in ML) will be measured in each group in the subset of participants who enter the study not on any background IPF medications, pirfenidone, nintedanib, or nerandomilast

Time frame
24 Weeks
4

To assess the effect of MTX-463 on the change from Baseline in the Living with Pulmonary Fibrosis (L-PF) Questionnaire total score

Change from Baseline to Week 24 in L-PF total score. The L-PF is scored on a scale of 0-100, with higher numbers indicating greater impairment.

Time frame
24 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mediar Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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