TTI-101 for Idiopathic Pulmonary Fibrosis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Tvardi Therapeutics, Incorporated
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
What safety data is available for TTI-101 in treating idiopathic pulmonary fibrosis?The provided research does not contain specific safety data for TTI-101 or its other names (C-188-9, TTI 101, TTI101) in the treatment of idiopathic pulmonary fibrosis. The abstracts mention other treatments and trials, but none specifically address TTI-101 or its safety profile.3471112
Do I need to stop my current medications for the trial?The trial does not specify if you need to stop all current medications. However, if you are taking nintedanib, your dose must be stable for at least 3 months before joining. If you stopped nintedanib, a 6-week washout is required. You cannot have taken pirfenidone within 3 months before joining. Check with the trial team for other medications.
Is the drug TTI-101 a promising treatment for idiopathic pulmonary fibrosis?The information provided does not mention TTI-101, so we cannot determine if it is a promising treatment for idiopathic pulmonary fibrosis based on the given data.13101112
What data supports the idea that TTI-101 for Idiopathic Pulmonary Fibrosis is an effective drug?The available research does not provide any data on TTI-101 for Idiopathic Pulmonary Fibrosis. The studies listed focus on different treatments for various types of pain and conditions, such as trigger point therapy, dry needling, and platelet-rich plasma for other ailments. Therefore, there is no information here to support the effectiveness of TTI-101 for Idiopathic Pulmonary Fibrosis.25689
Eligibility Criteria
This trial is for people with idiopathic pulmonary fibrosis (IPF) who have a life expectancy of at least 12 months, can maintain oxygen levels with minimal support, and have not had significant IPF improvement in the past year. They should be on a stable dose of nintedanib or off it for 6 weeks, and meet certain lung function criteria.Treatment Details
The study tests TTI-101's safety and tolerability against a placebo over 12 weeks. Participants will take TTI-101 orally every day to see how well they tolerate it and if there are any benefits in treating IPF.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TTI-101 800 mg/dayExperimental Treatment1 Intervention
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
Group II: TTI-101 400 mg/dayExperimental Treatment1 Intervention
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a matching placebo BID for 12 weeks.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California Irvine (UCI) HealthOrange, CA
University of FloridaGainesville, FL
UHealth - University of Miami Health SystemsMiami, FL
Loyola University Medical CenterMaywood, IL
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Who is running the clinical trial?
Tvardi Therapeutics, IncorporatedLead Sponsor
References
[Drug treatments for idiopathic pulmonary fibrosis]. [2019]Idiopathic pulmonary fibrosis is a disease of unknown cause characterized by cough, progressive dyspnea, restrictive respiratory disorder, a typical honeycomb aspect on the high-resolution CT-scan, and usual interstitial pneumonia at histological examination of the lung biopsy. Most patients die 3 to 8 years after diagnosis. Current treatment is based on a combination of corticosteroids and immunosuppressants, but the efficacy of treatment remains a matter of debate. New therapeutics currently under evaluation in controlled clinical trials include interferon-gamma, pirfenidone, N-acetylcysteine, etanercept (anti-TNFalpha), bosentan (endothelin receptor antagonist), imatinib (tyrosine-kinases inhibitor of the PDGF receptor), etc. At the same time, new compounds showing efficacy in experimental models of fibrosis and the development of new pathophysiological concepts open new perspectives both in terms of concept and clinical practice.
Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. [2022]This systematic review assessed the available published evidence on the efficacy and safety of using trigger point injection (TPI) to treat patients with chronic non-malignant musculoskeletal pain that had persisted for at least 3 months.
[Treatment of pulmonary fibrosis. New substances and new interventions]. [2021]Idiopathic pulmonary fibrosis is a chronic progressive lung disease with poor prognosis. The IFIGENIA trial showed that antioxidative therapy with N-acetylcysteine versus placebo for patients under treatment with prednisone plus azathioprine significantly slowed the deterioration of pulmonary function after 12 months. A number of other drugs have recently been evaluated in large multicenter placebo-controlled trials. Etanercept, interferon-γ, bosentan, ambrisentan, imatinib, and sildenafil did not show efficacy. The antifibrotic active ingredient pirfenidone is the first drug approved for the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis in the European Union. Approval was based on the results of 4 randomized, placebo-controlled clinical trials including more than 1,100 patients. Pirfenidone slowed the decline in lung function and reduced the risk of disease progression. Side effects include gastrointestinal discomfort, skin reactions, including photosensitivity, and rarely increased liver enzymes.
Immunosuppressive therapy for autoimmune lung diseases. [2012]This article focuses on issues of safety and monitoring when immunosuppressive pharmacologic therapies are prescribed for the treatment of connective tissue disease (CTD)-associated interstitial pneumonias, vasculitides, and bronchiolitis. Prospective, randomized placebo-controlled clinical trials have yet to be performed to evaluate the efficacy and safety of various immunosuppressive agents used to treat patients with CTD-interstitial lung disease or idiopathic interstitial pneumonias other than idiopathic pulmonary fibrosis (idiopathic usual interstitial pneumonia) that are not associated with the presence of CTD. Knowledge of their potential toxicities and interactions with other drugs combined with the adoption of a systematic approach to monitoring therapy can minimize life-threatening reactions.
Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. [2022]The aim of this study was to determine whether the dry needling of myofascial trigger points (MTrPs) is superior to placebo in the prevention of pain after total knee arthroplasty. Forty subjects were randomised to a true dry needling group (T) or to a sham group (S). All were examined for MTrPs by an experienced physical therapist 4-5 hours before surgery. Immediately following anesthesiology and before surgery started, subjects in the T group were dry needled in all previously diagnosed MTrPs, while the S group received no treatment in their MTrPs. Subjects were blinded to group allocation as well as the examiner in presurgical and follow-up examinations performed 1, 3, and 6 months after arthroplasty. Subjects in the T group had less pain after intervention, with statistically significant differences in the variation rate of the visual analogue scale (VAS) measurements 1 month after intervention and in the need for immediate postsurgery analgesics. Differences were not significant at 3- and 6-month follow-up examinations. In conclusion, a single dry needling treatment of MTrP under anaesthesia reduced pain in the first month after knee arthroplasty, when pain was the most severe. Results show a superiority of dry needling versus placebo. An interesting novel placebo methodology for dry needling, with a real blinding procedure, is presented.
Trigger Point Manual Therapy for the Treatment of Chronic Noncancer Pain in Adults: A Systematic Review and Meta-analysis. [2019]To determine the effectiveness of trigger point manual therapy (TPMT) for reducing chronic noncancer pain and associated problems in adults, by analyzing all relevant randomized controlled trials (RCTs).
Pirfenidone in patients with idiopathic pulmonary fibrosis and more advanced lung function impairment. [2020]Patients with idiopathic pulmonary fibrosis (IPF) demonstrate a range of lung function impairment. However, the efficacy of antifibrotics compared with placebo has not been assessed in patients with more advanced disease. This post-hoc analysis investigated the efficacy and safety of pirfenidone versus placebo in patients with IPF and more advanced lung function impairment, defined as percent predicted forced vital capacity (%FVC)
Platelet rich plasma versus placebo for the management of Achilles tendinopathy: protocol for the UK study of Achilles tendinopathy management (ATM) multi-centre randomised trial. [2021]In the UK, 150 000 people every year experience mid-substance Achilles tendinopathy. Typically patients are offered a range of treatment options such as exercise, electrotherapy, injections and surgery. With large variations in current practice, there is a pressing need to establish which treatments are effective and which are not. This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy.
Qualitative Sensory Testing in Outcome Prediction of Transforaminal Epidural Steroid Injection for Chronic Painful Unilateral Lumbosacral Radiculopathy: Prospective Observational Study. [2021]Transforaminal epidural steroid injection (TFESI) is widely practiced for the treatment of radicular pain. As its effectiveness is still subject to debate, a better patient selection for TFESI is necessary. We aimed to evaluate the potential of bedside-suitable qualitative sensory testing (QualST) to determine the early effectiveness of TFESI for the treatment of chronic lumbosacral radiculopathy (LSR)-related pain.
Efficacy of Pirfenidone vs. Placebo in Unclassifiable Interstitial Lung Disease, by Surgical Lung Biopsy Status: Data From a post-hoc Analysis. [2022]Approximately 12-13% of patients with interstitial lung disease (ILD) are diagnosed with unclassifiable ILD (uILD), often despite thorough evaluation. A recent Phase 2 study (NCT03099187) described a significant effect of pirfenidone vs. placebo on forced vital capacity (FVC) measured by site spirometry in patients with progressive fibrosing uILD (hereafter referred to as the pirfenidone in uILD study). Here, we present the results from a post-hoc analysis of this study to assess patient baseline characteristics and the efficacy of pirfenidone vs. placebo analyzed by surgical lung biopsy (SLB) status. Mean FVC (mL) change over 24 weeks was included as a post-hoc efficacy outcome. Of 253 randomized patients, 88 (34.8%) had a SLB and 165 (65.2%) did not. Baseline characteristics were generally similar between SLB subgroups; however, patients who had a SLB were slightly younger and had a higher 6-min walk distance than those without a SLB. Mean FVC change over 24 weeks for pirfenidone vs. placebo was -90.9 vs. -146.3 mL, respectively, in patients who had a SLB, and 8.2 vs. -85.3 mL, respectively, in patients without a SLB. Overall, the results from the post-hoc analysis identified that pirfenidone may be an effective treatment in progressive fibrosing uILD over 24 weeks, irrespective of SLB status; however, caution should be taken when interpreting these data due to several limitations. There are differences in the treatment effect of pirfenidone between the subgroups that require further pathological and radiological investigation. In this manuscript, we also descriptively compared baseline characteristics from the overall pirfenidone in uILD study population with other uILD populations reported in the literature, with the aim of understanding if there are any similarities or differences within these cohorts. Most baseline characteristics for patients in the pirfenidone in uILD study were within the ranges reported in the literature; however, ranges were wide, highlighting the heterogeneity of uILD populations.
Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis. [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This plain language summary describes the main findings from a trial in people with idiopathic pulmonary fibrosis (also called IPF) that was recently published in the New England Journal of Medicine. IPF is a rare disease, where the lungs become more and more scarred, with breathing and oxygen uptake becoming increasingly difficult. This trial looked at the medication BI 1015550 as a potential treatment for IPF. It compared BI 1015550 to placebo (a dummy drug that does not contain any active ingredients) to investigate the effectiveness of the drug in treating people with IPF. The study also looked at the additional medical issues (referred to as adverse events) reported during the study. Some participants took approved treatments to reduce scarring (nintedanib or pirfenidone), and some did not.
External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources. [2023]Rationale: Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, but the direct comparability of ECs versus concurrent controls is unknown. Objectives: To develop IPF ECs by fit-for-purpose data standards to historical randomized clinical trial (RCT), multicenter registry (Pulmonary Fibrosis Foundation Patient Registry), and electronic health record (EHR) data and to evaluate endpoint comparability among ECs and the phase II RCT of BMS-986020. Methods: After data curation, the rate of change in FVC from baseline to 26 weeks among participants receiving BMS-986020 600 mg twice daily was compared with the BMS-placebo arm and ECs using mixed-effects models with inverse probability weights. Measurements and Main Results: At 26 weeks, the rates of change in FVC were -32.71 ml for BMS-986020 and -130.09 ml for BMS-placebo (difference, 97.4 ml; 95% confidence interval [CI], 24.6-170.2), replicating the original BMS-986020 RCT. RCT ECs showed treatment effect point estimates within the 95% CI of the original BMS-986020 RCT. Pulmonary Fibrosis Foundation Patient Registry ECs and EHR ECs experienced a slower rate of FVC decline compared with the BMS-placebo arm, resulting in treatment-effect point estimates outside of the 95% CI of the original BMS-986020 RCT. Conclusions: IPF ECs generated from historical RCT placebo arms result in comparable primary treatment effects to that of the original clinical trial, whereas ECs from real-world data sources, including registry or EHR data, do not. RCT ECs may serve as a potentially useful supplement to future IPF RCTs.