30:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 2f:T429,{"@context":"https://schema.org","@type":"CollectionPage","name":"Randomized Controlled Trial (Phase 2, Long-Term Extension): study design Research & Clinical Takeaways","description":"Explore peer-reviewed papers on Randomized Controlled Trial (Phase 2, Long-Term Extension) (study design). Clinician-written summaries and actionable practice insights. Updated daily.","url":"https://www.reachrx.ai/hub/tag/study_design/Randomized%20Controlled%20Trial%20(Phase%202%2C%20Long-Term%20Extension)","breadcrumb":{"@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.reachrx.ai"},{"@type":"ListItem","position":2,"name":"Research Hub","item":"https://www.reachrx.ai/hub"},{"@type":"ListItem","position":3,"name":"Study Designs","item":"https://www.reachrx.ai/hub/tag/study_design"},{"@type":"ListItem","position":4,"name":"Randomized Controlled Trial (Phase 2, Long-Term Extension)","item":"https://www.reachrx.ai/hub/tag/study_design/Randomized%20Controlled%20Trial%20(Phase%202%2C%20Long-Term%20Extension)"}]}}31:T400,Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants.32:T920,The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn's disease. Efficacy and safety through 5 years are reported. After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups. Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants. Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411. Guselkumab demonstrated durable clinical and endoscopic efficacy and remained well tolerated through up to 5 years in the phase 2 GALAXI 1 study.33:Tbb7,Abstract Background The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn’s disease. Efficacy and safety through 5 years are reported. Methods After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups. Results Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants. Conclusions Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications. Clinical trial registration A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"$2f"}}]],["$","$L30",null,{"title":"Randomized Controlled Trial (Phase 2, Long-Term Extension): Research & Clinical Takeaways","description":"Browse Randomized Controlled Trial (Phase 2, Long-Term Extension) research papers with clear, practical takeaways for your clinical practice.","papers":[{"doi":"10.1093/ibd/izag055","pmid":"42065683","title":"Five-year efficacy and safety of guselkumab for moderately to severely active Crohn’s disease: Results from the phase 2 GALAXI 1 trial","journal_title":"Inflammatory Bowel Diseases","journal_issn":"1078-0998","published_at":"2026-05-01T00:00:00.000Z","url":"https://doi.org/10.1093/ibd/izag055","source_score":7,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-05-09","doi":"10.1093/ibd/izag055","days":"7","issn":"1078-0998","rank":"9","field":"Clinical Medicine","score":"7","category":"Gastroenterology & Hepatology","categories":["Gastroenterology & Hepatology"],"_categories":["Gastroenterology & Hepatology"]},"pubmed":{"doi":"10.1093/ibd/izag055","title":"Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial.","journal":"Inflammatory bowel diseases","methods":"","results":"$31","abstract":"$32","keywords":["Crohn’s disease","efficacy","guselkumab","long-term follow-up","safety"],"pubmed_id":"42065683","conclusions":"","publication_date":"2026-05-01T00:00:00"},"crossref":{"DOI":"10.1093/ibd/izag055","URL":"https://doi.org/10.1093/ibd/izag055","ISSN":["1078-0998","1536-4844"],"link":[{"URL":"https://academic.oup.com/ibdjournal/advance-article-pdf/doi/10.1093/ibd/izag055/68200439/izag055.pdf","content-type":"application/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https://academic.oup.com/ibdjournal/advance-article-pdf/doi/10.1093/ibd/izag055/68200439/izag055.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Five-year efficacy and safety of guselkumab for moderately to severely active Crohn’s disease: Results from the phase 2 GALAXI 1 trial"],"author":[{"given":"Anita","family":"Afzali","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of Cincinnati College of Medicine , Cincinnati, OH,"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele , Milan,"}]},{"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Unit, University of Calgary , Calgary, AB,"}]},{"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, University of Chicago Medicine , Chicago, IL,"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai Dr. Henry D. 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conservative and more appropriate for clinical interpretation.","value_numeric":null},{"paper_doi":"10.1093/ibd/izag055","tag_type":"warning","value":"The brand name 'Tremfya' is approved for psoriasis/PsA; guselkumab is not yet approved for Crohn's disease as of the publication date — brand tag reflects the molecule, not an approved CD indication.","value_numeric":null},{"paper_doi":"10.1093/ibd/izag055","tag_type":"warning","value":"The study was not powered for statistical comparisons; all between-group and vs.-placebo comparisons at 5 years are exploratory only.","value_numeric":null}],"summaries":{"what_studied":"The phase 2 GALAXI 1 randomized trial evaluated the long-term (up to 5 years/week 240) efficacy and safety of subcutaneous guselkumab (an IL-23p19 inhibitor) in adults with moderately to severely active Crohn's disease, including both biologic-naive and biologic-experienced participants.","key_result":"At week 240 (as-observed), 97.7% achieved clinical remission and 51.7% achieved endoscopic remission among continuing participants (n=87). By NRI analysis of all randomized participants (n=176/185), clinical remission was 46.0% and endoscopic remission rates were similarly durable. Responses were consistent across biologic-naive and biologic-inadequate-response subgroups (~97% clinical remission, ~54% endoscopic remission in both). Serious adverse events, serious infections, and discontinuations due to adverse events remained low throughout.","limitations":"Phase 2 trial only — not powered for statistical comparisons between dose groups or vs. placebo at 5 years. As-observed analysis is subject to attrition bias (only 87 of 185 randomized participants had data at week 240). No active comparator arm for long-term assessment.","practice_takeaway":"Guselkumab shows durable clinical and endoscopic efficacy through 5 years in Crohn's disease, with a favorable long-term safety profile — results that support its potential as a sustained maintenance option pending phase 3 confirmation. Clinicians should note these are phase 2 data and not yet sufficient to change standard-of-care practice."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Randomized Controlled Trial (Phase 2, Long-Term Extension)"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Randomized Controlled Trial (Phase 2, Long-Term Extension)"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Randomized Controlled Trial (Phase 2, Long-Term Extension)"}}}]]

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