Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

A Randomized, Double-Blind, Three-Period Crossover Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Risankizumab

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 223662

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Body mass index (BMI) is >= 18.0 to <= 30.0 kg/m2.

Exclusion Criteria:

• Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
• Any evidence of a concomitant disease judged as clinically relevant by the investigator.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any other uncontrolled medical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants will receive Regimen A (15-minute autoinjector (AI) warm-up time) in Period 1, Regimen B (30-minute AI warm-up time) in Period 2 followed by Regimen C (45-minute AI warm-up time) in Period 3.	Drug: Risankizumab; Subcutaneous autoinjector; Other Names: SKYRIZI
Experimental: Group 2; Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3.	Drug: Risankizumab; Subcutaneous autoinjector; Other Names: SKYRIZI
Experimental: Group 3; Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3.	Drug: Risankizumab; Subcutaneous autoinjector; Other Names: SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Injection Site Pain Assessed Using Visual Analog Scale	Injection site-related pain assessments will be recorded directly by the participant using a VAS after the injection is complete (within approximately 5 minutes and 1 hour post-dose).	Up to approximately 15 days
Percentage of Participants Experiencing Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Up to approximately 155 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)	SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience).	Up to approximately 15 days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Risankizumab
• Other Study ID Numbers: M20-200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes