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QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

ABSTRACT: The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2327310 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

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Project description:UNIFI was a randomized placebo-controlled phase 3 clinical trial evaluating the efficacy and safety of ustekinumab (ClinicalTrials.gov Identifier: NCT02407236). Gene expression profiling by microarrays was carried out at baseline on biopsies from the sigmoid colon (15-20cm from anal verge) of patients (n=550) with moderate-to-severe ulcerative colitis and of healthy subjects (n=18). Ulcerative colitis patients received placebo (n=186) or ustekinumab (n=364). The effects of two different dosages were investigated: 130mg (n=180) and 6mg/kg (n=184).

2022-08-08 | GSE206285 | GEO

Efficacy and safety of ustekinumab treatment in adults with moderate-to-severe atopic dermatitis

Project description:This was a phase II, randomized, placebo-controlled, double-blinded single center study (clinicaltrials.gov: NCT01806662) to investigate safety and efficacy of ustekinumab treatment in moderate-to-severe AD patients. Patients underwent 1:1 randomization using a computer generated subject randomization table by an unblinded pharmacist. to Subjects received subcutaneous ustekinumab or placebo at weeks 0, 4, and 16 with a crossover to the other agent (either ustekinumab or placebo) at weeks 16, 20, and 32 (Figure 1A) to ensure patient retention.

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Efficacy and safety of ustekinumab treatment in patients with Crohn's disease

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2022-09-08 | GSE207022 | GEO

Safety and Efficacy of Atuzabrutinib Topical Gel in Patients with Mild-to-Moderate Atopic Dermatitis: Findings from Phase 2a Trial

Project description:This phase 2a study of atuzabrutinib (PRN473/SAR444727), a Bruton tyrosine kinase inhibitor, comprised of a double-blind placebo-controlled treatment period and an open-label uncontrolled treatment period and evaluated safety and efficacy of atuzabrutinib 5% gel vs placebo (in double-blind period) in patients with mild-to-moderate atopic. dermatitis (AD). Patients aged 18–70 years diagnosed with mild-to-moderate AD (N=39) for at least 6 months were included in the study. During the double-blinded Period (Days 1–14), two target lesions with a difference ≤1 point in total sign score (TSS) were randomized 1:1 to atuzabrutinib or matching placebo twice daily. During open-label period (Days 15–42), patients continued to treat the assigned areas and other AD-affected lesions (except scalp, palms, soles and genitals) with atuzabrutinib BID. The objective is to evaluate the safety, tolerability, PK and preliminary efficacy of atuzabrutinib in patients with mild to moderate AD. RNA sequencing analysis was performed to understand the target immune cell expression in lesional skin biopsies versus normal skin and the effect of atuzabrutinib.

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Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

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Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus [skin]

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2017-06-23 | GSE100093 | GEO

Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus [blood]

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Prediction of response to FOLFOX

Project description:The patients who underwent surgery for primary lesions were examined. All patients had metastatic or recurrent CRC and received modified FOLFOX6. Responders and nonresponders were determined based on the best observed response at the end of the first-line treatment, mFOLFOX6. Gene-expression profiles of primary CRC were determined using Human Genome GeneChip arrays U133. Colorectal cancer patients who had undergone surgical resection of colorectal cancer were studied. To identify molecular signatures to predict response to mFOLFOX6 regimen, gene expression profiles were compared between Reponder and Non-responder. Some patients are overlapped with Bevacizumab therapy.

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