[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Scholar Rock, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596567","phase-2-a-study-to-evaluate-how-apitegromab-works-in-subjects-who-are-less-than-2-years-old-and-have-spinal-muscular-atrophy-100596567",false,"NCT07047144","A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy","A Phase 2, Double-Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Apitegromab in Subjects \u003C2 Years Old With Spinal Muscular Atrophy (SMA)","OPAL","Inclusion Criteria:\n\n1. Is \\\u003C2 years old at the time of the informed consent\n2. Had a gestational age of ≥35 weeks and gestational body weight ≥2.0 kg at birth\n3. Has confirmed diagnosis of 5q autosomal recessive SMA\n4. Has confirmed presence of SMN2 gene copy(ies)\n5. Must have been treated with an approved SMN1-targeted therapy (ie, onasemnogene abeparvovec-xioi) or are continuing to be treated with an approved SMN2-targeted therapy (ie, nusinersen or risdiplam)\n6. Body weight for age is no less than 1st percentile based on the WHO Child Growth Standards at the Screening Visit\n7. Has delayed motor milestones for age attributed to SMA at the discretion of the Investigator or a CHOP-INTEND score \\\u003C55\n\nExclusion Criteria:\n\n1. Nutritional status that is not anticipated to be stable throughout the study or medical necessity for a gastric feeding tube, where most feeds are administered by this route\n2. Major orthopedic issues such as severe scoliosis or severe contractures or interventional procedure, including spine or hip surgery, which is considered to have the potential to substantially limit the ability of the subject to be evaluated on any motor function outcome measures, within 6 months before Screening or anticipated during the study\n3. Any other physical limitations (eg, the subject requires cast for contractures) that would prevent the subject from undergoing motor function outcome measures throughout the study.","ALL","2 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This double-blind, Phase 2, multiple-dose study will be conducted to evaluate the PK\u002FPD, efficacy, safety, and tolerability of apitegromab in subjects \\\u003C2 years old with 5q autosomal recessive SMA who have delayed motor milestones for their age attributed to SMA at the discretion of the Investigator or a Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) score \\\u003C55.",[27,28,29,30,31,32],"Spinal Muscular Atrophy","SMA","Spinal Muscular Atrophy Type 2","Spinal Muscular Atrophy Type 3","Neuromuscular Manifestations","Anti-myostatin","RECRUITING","2026-04-29",{"date":36,"type":37},"2026-05-01","ACTUAL",{"date":39,"type":37},"2025-09-15",{"date":41,"type":21},"2029-03",{"name":43,"class":44},"Scholar Rock, Inc.","INDUSTRY",25,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100627104","phase-1-a-single--and-multiple-ascending-dose-study-of-srk-439-in-healthy-adults-100627104","NCT07444294","A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults","A Phase 1 Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRK-439 in Healthy Adults","Key Inclusion Criteria:\n\n1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent\n2. BMI of ≥18 kg\u002Fm2 to ≤35 kg\u002Fm2 (inclusive) at screening\n\nExclusion Criteria:\n\n1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.\n2. History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.\n3. Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.\n4. Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study.\n5. Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure\n6. Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.",true,"18 Years","55 Years",{"count":57,"type":21},76,[59],"PHASE1","A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults",[62],"Healthy","2026-02-24",{"date":65,"type":37},"2026-03-02",{"date":67,"type":37},"2025-11-21",{"date":69,"type":21},"2027-06-09",{"name":43,"class":44},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100626399","phase-2-phase-2-study-evaluating-apitegromab-for-the-treatment-of-fshd-100626399","NCT07435129","Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study Evaluating the Efficacy and Safety of Apitegromab in Participants With Facioscapulohumeral Muscular Dystrophy (FORGE)","Inclusion Criteria:\n\n1. Male or female participants, 18 to 60 years of age at the time of informed consent.\n2. Genetic diagnosis of FSHD Type 1 or FSHD Type 2, confirmed with the appropriate documentation from an accredited laboratory\n3. Clinical severity score of 1.5 to 3.0 (Ricci score; range 0 to 5), inclusive, at screening\n4. Baseline 10-meter walk\u002Frun test time ≤5 seconds\n\nExclusion Criteria:\n\n1. Prior history of a hypersensitivity reaction to a mAb or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab\n2. Treatment with other investigational drugs in a clinical trial within 3 months or 5 half-lives, whichever is longer, before screening\n3. Previous treatment with apitegromab, or with other anti-myostatin therapies, including activin receptor antagonists\n4. Current or prior use of anabolic steroids, growth hormones, glucagon-like peptide-1 receptor agonist or other substances with known effects on muscle.\n5. Use of therapies with potentially significant muscle effects (eg, androgens, insulin-like growth factor, growth hormone, systemic beta-agonist, botulinum toxin, or muscle relaxants or muscle-enhancing supplements) or potentially significant neuromuscular effects (eg, acetylcholinesterase inhibitors) within 60 days before screening\n6. Use of systemic or corticosteroids within 60 days prior to screening. Inhaled or topical steroids are allowed.\n7. Pregnant or breastfeeding.\n8. Contraindications for MRI that may include, but are not limited to, certain implanted electronic devices, cochlear implants, metallic foreign bodies, vascular clips, and metallic implants; or claustrophobia, contrast agent allergies, inability to lie still, or external medical devices that may not be removed.\n\nHistory of alcoholism, or illicit drug use (drugs that are illegal and have not been prescribed).\n\nTaking medications that impede coagulation or platelet aggregation or has a history or active coagulopathy disorder.\n\nAny acute or comorbid condition interfering with the well-being of the participant within 7 days prior to screening, including active systemic infection, the need for acute treatment, or inpatient observation due to any reason","60 Years",{"count":81,"type":21},60,[24],"A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD",[85,86],"Facioscapulohumeral Muscular Dystrophy","FSHD","NOT_YET_RECRUITING",{"date":89,"type":37},"2026-02-27",{"date":91,"type":21},"2026-08",{"date":93,"type":21},"2028-12",{"name":43,"class":44},""]