April. 25, 2024 |
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Oct. 08, 2024 |
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jRCT2031240052 |
CONQUEST Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis (CONQUEST ) |
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Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis (CONQUEST ) |
Kay Richard |
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Medpace UK Limited |
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Wallace House 17-21 Maxwell Place Stirling, Scotland, United Kingdom |
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44-7747621827 |
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R.Kay@medpace.com |
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Yamada Yuya |
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Medpace Japan KK |
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1-5-8, Jingumae, Shibuya-ku, Tokyo |
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+81-8077492473 |
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rsjapan1@medpace.com |
Recruiting |
July. 01, 2024 |
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19 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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1. Male or female at least 18 years of age at the time of signed informed consent; |
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1. Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis (TB), sarcoidosis, lung mass, or otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator) |
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18age old over | ||
No limit | ||
Both |
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Patients with interstitial lung disease (ILD) secondary to systemic sclerosis (SSc) (SSc-ILD) |
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There will be multiple interventional regimens, each consisting of the study participants receiving either the active IP or its matching placebo. |
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To evaluate the efficacy of the investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in forced vital capacity (mL), measured in study participants with SSc-ILD. |
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Scleroderma Research Foundation, Inc. |
Juntendi Univetsity Hospital Institutional Review Board | |
3-1-3 Hongo, Bunkyo-ku, Tokyo, Tokyo | |
Approval | |
June. 28, 2024 |
No |
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NCT06195072 | |
ClinicalTrials.gov |
United States/United Kingdom/Thailand/Taiwan /Spain/South Korea /Portugal/Poland/Norway/Netherlands/Mexico/Malaysia/Italy/Israel/India/Germany/France/Denmark/China/Chile/Belgium/Austria/Australia/Argentina |