scholarly journals Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I–III Clinical Trials

2019 ◽  
Vol 58 (10) ◽  
pp. 1309-1321 ◽  
Author(s):  
Ahmed A. Suleiman ◽  
Mukul Minocha ◽  
Amit Khatri ◽  
Yinuo Pang ◽  
Ahmed A. Othman
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Population Pharmacokinetics ◽  
Plaque Psoriasis ◽  
Severe Plaque Psoriasis

scholarly journals Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

2018 ◽  
Vol 13 (5) ◽  
pp. 494-510 ◽  
Author(s):  
Jill A. Fisher ◽  
Lisa McManus ◽  
Megan M. Wood ◽  
Marci D. Cottingham ◽  
Julianne M. Kalbaugh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Employment Status ◽  
Qualitative Interviews ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Financial Compensation ◽  
Trial History

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea

2021 ◽  
pp. 155626462110342
Author(s):  
Ji-Hye Seo ◽  
Ock-Joo Kim ◽  
Sang-Ho Yoo ◽  
Eun Kyung Choi ◽  
Ji-Eun Park
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Health Science ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Financial Reward ◽  
Therapeutic Purpose ◽  
The Republic

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered “university graduation” and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers’ participation in research was “financial reward.” Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis

2019 ◽  
Vol 54 (4) ◽  
pp. 380-387 ◽  
Author(s):  
Wendy Li ◽  
Rima Ghamrawi ◽  
Wasim Haidari ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Plaque Psoriasis ◽  
Data Extraction ◽  
Severity Index ◽  
Phase Iii ◽  
Cochrane Library ◽  
Severe Plaque Psoriasis ◽  
Phase Iii Clinical Trials ◽  
Interleukin 23

Objective: Risankizumab (Skyrizi), an interleukin-23 (IL-23) antagonist, was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in April 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this drug. Data Sources: A systematic literature review was performed using the terms “psoriasis AND risankizumab” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician’s Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies. Conclusion: Risankizumab is a newly FDA-approved IL-23 inhibitor that shows particular promise in the treatment of plaque psoriasis. Based on this review, it is an effective and safe addition to the armamentarium of biologics that are currently available.

A Tale of Three Cultures

2020 ◽  
pp. 75-99
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
West Coast ◽  
East Coast ◽  
Trial Participation ◽  
Phase I Trials ◽  
Hybrid Culture ◽  
Active Pursuit

Despite similar financial goals among healthy volunteers, there are regional differences in the culture of Phase I participation. Chapter 3 focuses on this theme to further unpack variations in how patterns of imbricated stigma influence healthy volunteers’ perceptions of Phase I trials, particularly with respect to the longevity of their study involvement. Specifically, East Coast participants tend to be well-networked as part of their long-term, active pursuit of clinical trials, but they often also express anti-capitalist critiques of the industry. In comparison, Midwesterners tend to be more passive about their trial participation, thinking of it as a short-term financial opportunity to counterbalance a temporary setback. West Coast participants occupy a hybrid culture between those of the East Coast and Midwest participants, actively seeking out new studies but expressing a distrust in the clinics and wanting to limit their study involvement. These regional cultures act as a prism for healthy volunteers’ perceptions of Phase I trials, shaping whether and how they adopt identities as research participants.

Efalizumab for the Treatment of Moderate to Severe Plaque Psoriasis

2005 ◽  
Vol 39 (9) ◽  
pp. 1476-1482 ◽  
Author(s):  
Joseph K Jordan
Keyword(s):  
Clinical Trials ◽  
T Cell Activation ◽  
Plaque Psoriasis ◽  
Systemic Therapy ◽  
Cell Activation ◽  
Data Extraction ◽  
Efficacy And Safety ◽  
Severe Plaque Psoriasis ◽  
Medline Search ◽  
Prior Systemic Therapy

OBJECTIVE: To review the pharmacology, efficacy, and safety of efalizumab for the treatment of moderate to severe plaque psoriasis. DATA SOURCES: A MEDLINE search (1966–May 2005%) using the key words hu1124, anti-CD11a, efalizumab, Raptiva, Xanelim, and psoriasis was conducted. References of identified articles were reviewed for additional citations. STUDY SELECTION AND DATA EXTRACTION: Clinical trials evaluating the pharmacology, efficacy, and safety of efalizumab for treatment of moderate to severe plaque psoriasis in adults were included in our review. DATA SYNTHESIS: Efalizumab's ability to inhibit the binding of CD11a, a subunit of leukocyte function–associated antigen type 1, to intracellular adhesion molecule 1 results in decreased T-cell activation and migration, 2 key steps in the immunopathogenesis of psoriasis. Results of clinical trials have demonstrated that efalizumab administered subcutaneously is a safe and effective treatment for moderate to severe plaque psoriasis. Efalizumab was well tolerated in trials, with the majority of adverse events arising with the first dose and decreasing with subsequent doses. The high cost of this agent and lack of head-to-head trials with other drugs will likely restrict its use to patients who have failed prior systemic therapy or phototherapy. CONCLUSIONS: Efalizumab is a safe and effective therapy for treatment of moderate to severe plaque psoriasis in patients who have failed prior systemic therapy or phototherapy.

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