ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07309432 के लिए एलर्जिक कंजंक्टिवाइटिस वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
रिजेनरॉन फार्मास्यूटिकल्सStudy of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy चरण III 350 किशोरावस्था
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07309432 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन एलर्जिक कंजंक्टिवाइटिस से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 10 जनवरी 2026 को हुई थी, और इसमें कुल 350 प्रतिभागियों के नामांकन की योजना है। रिजेनरॉन फार्मास्यूटिकल्स इस परीक्षण का नेतृत्व कर रहे हैं और इसके 15 जून 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 10 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo.
Th...
और दिखाएँआधिकारिक शीर्षक
A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy
स्वास्थ्य स्थितियां
एलर्जिक कंजंक्टिवाइटिसअन्य अध्ययन आईडी
- R5713-5715-ALG-2556
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-01-10
अंतिम अद्यतन प्रकाशित
2026-02-10
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-06-15
नामांकन (अनुमानित)
350
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
भर्ती जारी
प्रमुख शब्द
Birch Pollen Allergy
Ocular allergy symptoms
Ocular allergy signs
Ocular allergy symptoms
Ocular allergy signs
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकREGN5713-5715 | REGN5713 Administered per protocol REGN5715 Administered per protocol |
प्रयोगात्मकREGN5713 | REGN5713 Administered per protocol |
प्रयोगात्मकREGN5715 | REGN5715 Administered per protocol |
प्लेसबो तुलना समूहPlacebo | प्लेसबो Administered per protocol |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Ocular itch score in participants receiving REGN5713-5715 compared to placebo | Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments | At Day 8 post-Conjunctival Allergen Challenge (CAC) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 8 post-CAC | |
Ocular itch score in participants receiving REGN5713-5715 compared to placebo | At Day 57 post-CAC | |
Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo | Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 8 post-CAC | |
Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo | The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a verbal rating scale ranging from 0 (none) to 3 (severe) for nasal congestion, nasal itching, rhinorrhea, and sneezing. | At Day 8 post-CAC |
Ocular itch score in participants receiving REGN5715 compared to placebo | At Day 8 and Day 57 post-CAC | |
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5715 compared to placebo | Baseline to Day 8 post-CAC | |
Conjunctival redness score in participants receiving REGN5715 compared to placebo | At Day 8 post-CAC | |
Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo | Baseline to Day 8 post-CAC | |
Ocular itch score in participants receiving REGN5713 compared to placebo | At Day 8 and Day 57 post-CAC | |
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo | Baseline to Day 8 post-CAC | |
Conjunctival redness score in participants receiving REGN5713 compared to placebo | At Day 8 post-CAC | |
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo | Baseline to Day 8 post-CAC | |
Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo | Area Under the Curve (AUC) of the mean wheal diameters | Baseline and at Day 8 post-CAC |
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713 | Baseline to Day 8 post-CAC | |
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715 | Baseline to Day 8 post-CAC | |
Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo | Baseline to Day 8 post-CAC | |
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 57 post-CAC | |
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 57 post-CAC | |
Ciliary redness score in participants receiving REGN5713-5715 compared to placebo | Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
Episcleral redness score in participants receiving REGN5713-5715 compared to placebo | Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
Total redness score in participants receiving REGN5713-5715 compared to placebo | The total redness score is calculated for CAC: range 0 to 12, where higher scores indicate worse responses (calculated as a sum of the bilateral averages for conjunctival redness score, graded 0 = none to 4 = extremely severe + ciliary redness score, graded 0 = none and 4 = extremely severe + episcleral redness score, graded 0 = none and 4 = extremely severe) | At Day 8 and Day 57 post-CAC |
Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo | Baseline and at Day 57 post-CAC | |
Percent change in birch tSPT in participants receiving REGN5715 compared to placebo | Baseline, at Day 8 and at Day 57 post-CAC | |
Percent change in birch tSPT in participants receiving REGN5713 compared to placebo | Baseline, at Day 8 and at Day 57 post-CAC | |
Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to Day 113 | |
Severity of TEAEs | Up to Day 113 | |
Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs) | Up to Day 113 | |
Concentrations of total REGN5713 is serum over time | Up to Day 113 | |
Concentrations of total REGN5715 is serum over time | Up to Day 113 | |
Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713 | Up to Day 113 | |
Magnitude of ADA to REGN5713 | Up to Day 113 | |
Occurrence of ADA responses to REGN5715 | Up to Day 113 | |
Magnitude of ADA to REGN5715 | Up to Day 113 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
12 Years
अध्ययन के लिए पात्र लिंग
सभी
- Positive SPT to birch allergen extract
- Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
- Positive CAC criteria
- Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
- Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
- A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening
Note: Other protocol defined Inclusion/Exclusion criteria apply.
रिजेनरॉन फार्मास्यूटिकल्सअध्ययन केंद्रीय संपर्क
संपर्क: Clinical Trials Administrator, 844-734-6643, [email protected]
1 1 देशों में अध्ययन स्थान
Massachusetts
Andover Eye Associates, Andover, Massachusetts, 01810, United States
भर्ती जारी