A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Primary Sjögren's Syndrome (pSS) With Moderate to Severe Symptom Burden

The goal of this clinical study is to learn if RSLV-132 improves the symptoms of pSS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:
Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
What are the blood levels of RSLV-132 over time?
What is the immune (antibody) response in the body to RSLV-132?
What is the safety profile of RSLV-132?
Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.
Participants will:
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device

开始日期2024-09-01

申办/合作机构

Resolve Therapeutics LLC

NCT04944121 / Completed临床2期

A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Post-acute COVID-19 (Long COVID)

The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome

开始日期2021-06-25

申办/合作机构

Resolve Therapeutics LLC

NCT03247686 / Completed临床2期

A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome

The present study will examine the role of circulating RNA complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene expression in blood cells. A number of biochemical and clinical parameters will be analyzed to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.

开始日期2017-02-01

申办/合作机构

Resolve Therapeutics LLC

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100 项与 RSLV-132 相关的临床结果

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100 项与 RSLV-132 相关的转化医学

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100 项与 RSLV-132 相关的专利（医药）

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项与 RSLV-132 相关的文献（医药）

2021-01-01·Arthritis & rheumatology (Hoboken, N.J.)1区 · 医学

Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren’s Syndrome: A Randomized Clinical Trial

1区 · 医学

Article

作者: Valadkhan, Saba ; Barone, Francesca ; Posada, James ; Gallagher, Peter ; Davies, Kristen ; Wilson, Douglas ; Ng, Wan‐Fai ; Burge, Daniel ; Fisher, Benjamin A. ; Jobling, Kerry ; Tarn, Jessica ; Casement, John

Objective:

To assess the safety and efficacy of RSLV‐132, an RNase Fc fusion protein, in a phase II randomized, double‐blind, placebo‐controlled clinical trial in patients with primary Sjögren’s syndrome (SS).

Methods:

Thirty patients with primary SS were randomized to receive treatment with RSLV‐132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV‐132 at a dose of 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐F), Profile of Fatigue (ProF), and the Digit Symbol Substitution Test (DSST).

Results:

Patients randomized to receive RSLV‐132 experienced clinically meaningful improvements in the ESSPRI score (P = 0.27), FACIT‐F score (P = 0.05), ProF score (P = 0.07), and DSST (P = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon‐inducible genes (Pearson’s correlations, each P < 0.05).

Conclusion:

Administration of RSLV‐132 improved severe fatigue, as determined by 4 independent patient‐reported measures of fatigue, in patients with primary SS.

2017-07-01·Lupus3区 · 医学

Safety, pharmacokinetics, and pharmacodynamics of RSLV-132, an RNase-Fc fusion protein in systemic lupus erythematosus: a randomized, double-blind, placebo-controlled study

3区 · 医学

Article

作者: Burge, D J ; Sherrer, Y ; Eisenman, J ; Byrnes-Blake, K ; Posada, J A ; Cohen, S B ; Lau, K ; Levin, R ; Kivitz, A J ; Martin, R W ; Smolak, P

Blood-borne RNA circulating in association with autoantibodies is a potent stimulator of interferon production and immune system activation. RSLV-132 is a novel fully human biologic Fc fusion protein that is comprised of human RNase fused to the Fc domain of human IgG1. The drug is designed to remain in circulation and digest extracellular RNA with the aim of preventing activation of the immune system via Toll-like receptors and the interferon pathway. The present study describes the first clinical study of nuclease therapy in 32 subjects with systemic lupus erythematosus. The drug was well tolerated with a very favorable safety profile. The approximately 19-day serum half-life potentially supports once monthly dosing. There were no subjects in the study that developed anti-RSLV-132 antibodies. Decreases in B-cell activating factor correlated with decreases in disease activity in a subset of patients.

项与 RSLV-132 相关的新闻（医药）

2024-05-13

·PRNewswire

Resolve Therapeutics Publishes Results of RSLV-132 Phase 2 Long COVID Study

MIAMI, May 13, 2024 /PRNewswire/ -- Resolve Therapeutics, a mid-stage clinical development company pioneering transformative therapies for autoimmune and post-viral illnesses, today announced the publication of its phase 2 long COVID results in Clinical Infectious Diseases. The publication entitled "Assessment of the Impact of RNase in Patients with Severe Fatigue Related to Post-Acute Sequelae of SARS-CoV-2 Infection (PASC): A randomized phase 2 trial of RSLV-132" evaluated the impact of RNase in one hundred and eight patients diagnosed with COVID-19 at least 6 months prior to baseline and with a history of continuous, severe fatigue. Participants received 6 doses of RSLV-132 or placebo over two months. The study measured fatigue and overall disease activity using the PROMIS SF 10a, FACIT-Fatigue, and physician's global assessment. Approximately 18 million Americans suffer the debilitating effects of long COVID. The most common symptoms are extreme fatigue, brain fog, immune dysregulation and depression or anxiety. Despite the large unmet medical need, A recent editorial in The Lancet identified only 12 pharmacological interventional clinical trials in development. Thus, very little progress has been made towards identifying drugs to treat the cardinal symptoms of long COVID. RSLV-132 has demonstrated significant clinical activity in improving autoimmune-related fatigue in Sjogren's syndrome. Results from the current long COVID phase 2 study suggest patients suffering from long COVID may also benefit from the removal of circulating RNA. "We are encouraged by the potential for RSLV-132 to improve the debilitating fatigue suffered by so many long COVID patients" commented Dr. James Posada chief executive officer of Resolve Therapeutics. "Interestingly, our data further suggests that women may respond better to RSLV-132 and digestion of latent viral RNA than men" added Dr. Posada. About RSLV-132 RSLV-132 is a non-immunosuppressive, biologic drug comprised of catalytically active human RNase1 fused to the Fc region of human IgG1. It is designed to remain in serum circulation and digest extracellular pathogenic RNA. RNA is the primary trigger of interferon and cytokine production that drives chronic inflammation in diseases such as SLE, Sjogren's. Recent studies suggest that RNA may play a role in post-viral illnesses such as PASC and ME/CFS as well. Therefore, removing it from circulation may decrease inflammation and improve the symptoms associated with these diseases. About Resolve Therapeutics Resolve is a private biotech company pioneering a transformative approach to autoimmune and post-viral diseases. The company is leveraging the extensive body of scientific discoveries that demonstrate the central role of pathogenic RNA molecules, weather self-derived or from viral sources, in driving inflammatory and neuroinflammatory symptoms. Resolve is actively developing RSLV-132 in mid-stage clinical development programs including SLE, Sjogren's syndrome, and post-acute sequelae of SARS-CoV-2 infection (PASC). For more information please visit: Contact: James Posada Resolve Therapeutics 208-727-7010 [email protected] SOURCE Resolve Therapeutics, LLC

临床2期临床结果siRNA

2024-02-12

·PRNewswire

Resolve Therapeutics Announces Publication of Lupus Clinical Trial Results

MIAMI, Feb. 12, 2024 /PRNewswire/ -- Resolve Therapeutics, a mid-stage clinical development biotechnology company pioneering first-in-class therapies for autoimmune diseases, today announced the publication of results from its phase 2a clinical trial of RSLV-132 in patients with Systemic Lupus Erythematosus (SLE) in Lupus Science & Medicine. The publication entitled "Evaluation of RNase therapy in systemic lupus erythematosus: a randomized phase 2a clinical trial of RSLV-132" describes a proof-of-concept study in SLE patients with moderate-severe cutaneous disease activity. The findings suggest that patients with Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) scores above nine respond preferentially to digestion of extracellular RNA as compared to patients with lower SLEDAI-2k scores less than nine. "We would like to express our deepest gratitude to the patients that participated in the study" commented Dr. James Posada chief executive officer of Resolve Therapeutics. "Mounting evidence substantiates the importance of extracellular RNA as a drug target in autoimmune diseases such as SLE and Sjogren's. Our study demonstrates the potential benefit of digesting circulating pathogenic RNA in selected SLE patients with active systemic disease and circulating RNA-containing autoantibodies" added Dr. Posada. About RSLV-132 RSLV-132 is a non-immunosuppressive, biologic drug comprised of catalytically active human RNase1 fused to the Fc region of human IgG1. It is designed to remain in serum circulation and digest extracellular pathogenic RNA in patients with autoimmune diseases. RNA is the primary trigger of interferon production and drives chronic inflammation in autoimmune diseases such as SLE and Sjogren's, therefore removing it from circulation may decrease inflammation and improve the symptoms associated with these autoimmune diseases. About Resolve Therapeutics Resolve is a private biotech company pioneering a completely new approach to autoimmune disease. The company is leveraging the extensive body of scientific discoveries that demonstrate the central role of pathogenic RNA molecules in autoimmune disease. Resolve is actively developing RSLV-132 in mid-stage clinical development programs icluding SLE, Sjogren's syndrome, and post-acute sequelae of SARS-CoV-2 infection (PASC). For more information please visit: Contact: James Posada Resolve Therapeutics 208-727-7010 [email protected] SOURCE Resolve Therapeutics, LLC

临床2期临床结果siRNA

2022-11-09

·PRNewswire

Resolve Therapeutics Completes Enrollment of Phase 2 Long Covid Clinical Trial

ST. PETERSBURG, Fla., Nov. 9, 2022 /PRNewswire/ -- Resolve Therapeutics, pioneering first-in-class, targeted, safe therapies for underserved autoimmune diseases, today announced that its phase 2 clinical trial of RSLV-132 in patients with long covid has been fully enrolled (NCT04944121). The randomized, double-blind, placebo-controlled study in patients with long covid who are suffering from debilitating fatigue has enrolled 113 participants into the study. The primary endpoint of the study will analyze an improvement in patient fatigue using the PROMIS SF 7a instrument. The last participant will complete the study in January and top-line data will be released in the first quarter of 2023. "We wish to extend our sincere thanks to the participants of the study. The knowledge gained through your participation will hopefully lead to a treatment for the tens of millions of patients suffering from long covid." Commented Dr. James Posada chief executive officer of Resolve Therapeutics. About RSLV-132 RSLV-132 is a safe, novel, targeted biologic drug designed to remove pro-inflammatory nucleic acids from the circulation of patients, which is one of the key triggers of multiple pro-inflammatory cascades. The compound consists of a catalytically active human RNase moiety fused to a human IgG1 Fc domain which digests RNA circulating in the blood and thereby decreases inflammation. About Resolve Therapeutics Resolve Therapeutics is pioneering safe, targeted therapies for underserved autoimmune diseases with large unmet medical need. The Company's lead compound, RSLV-132, a first-in-class investigational treatment in development for lupus and Sjogren's syndrome. The drug eliminates the inflammatory material found in the blood of patients with autoimmune diseases, thereby preventing the activation of numerous pro-inflammatory cascades. RSLV-132 removes just the inflammatory stimulating molecules, without shutting down the immune system or interfering with key steps in the innate immune system. For more information, visit . Contacts: James Posada Resolve Therapeutics 208-727-7010 [email protected] SOURCE Resolve Therapeutics, LLC

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100 项与 RSLV-132 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
新冠肺炎后遗症	临床2期	美国	Resolve Therapeutics LLC	2021-06-25
原发性干燥综合征	临床2期	英国	Resolve Therapeutics LLC	2017-02-01
系统性红斑狼疮	临床2期	美国	Resolve Therapeutics LLC	2016-01-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03247686 (CTgov)	临床2期	原发性干燥综合征	28	Placebo (Placebo)	觸繭鬱淵膚積鹹構鏇觸(衊積廠觸範餘構鏇顧餘) = 鏇網製簾糧鹽艱憲餘範網製獵蓋簾鑰膚觸願遞 (艱顧網鏇範憲獵艱齋壓, 範製顧範築製範鑰獵遞 ~ 築簾積築膚構繭鑰鑰簾) 更多	-	2021-04-02
				RSLV-132 (RSLV-132)	網蓋網淵製獵壓繭選齋(鑰窪壓獵壓繭廠齋淵積) = 夢醖艱構築製齋衊鬱積鹹餘獵範選鹽構廠鬱選 (積構膚窪糧鑰鑰衊衊廠, 範壓鹽襯製壓鏇構餘糧 ~ 範繭夢簾夢製蓋遞築蓋) 更多
NCT02660944 (CTgov)	临床2期	系统性红斑狼疮	64	RSLV-132 (RSLV-132)	窪淵醖憲構顧鏇齋築齋(廠衊鹹選範壓壓淵遞繭): Mean Difference (Final Values) = 0.37 (95% CI, -3.42 ~ 4.15), P-Value = 0.845; Mean Difference (Final Values) = -0.48 (95% CI, -4.66 ~ 3.70), P-Value = 0.818	-	2021-03-10
				Placebo (Placebo)
NCT03247686 (Pubmed \| Arthritis Rheumatol) 人工标引	临床2期	疲劳 \| 原发性干燥综合征	28	RSLV-132	選醖網淵膚淵憲廠顧遞(糧鏇淵鹽醖築繭繭夢觸): P-Value = 0.02 更多	积极	2021-01-01
				Placebo
EULAR2019	临床2期	原发性干燥综合征 anti-Ro \| IFN gene expression signature	-	RSLV-132 10 mg/kg IV	遞餘範鬱觸鹹鏇齋鬱鑰(鹹醖鬱鑰廠觸膚範夢糧) = 願鹽艱淵衊壓餘製簾鏇選餘繭獵築築夢廠廠鏇 (鏇膚鑰製廠襯積獵選餘 ) 更多	-	2019-06-12
				Placebo	憲積壓艱壓齋顧壓蓋築(範糧鏇夢鹹鬱壓醖繭獵) = 襯製鑰構壓淵築鑰遞構衊鬱鏇廠鏇鏇壓餘醖夢 (範獵製構膚蓋膚餘艱蓋 )