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OpenTrials
Completed

NCT Number: NCT05274087

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 223662

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

Subcutaneous autoinjector

Other names: SKYRIZI

Primary outcomes

  1. Change in Injection Site Pain Assessed Using Visual Analog Scale

    Time frame: Up to approximately 15 days

    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).

  2. Percentage of Participants Experiencing Adverse Events

    Time frame: Up to approximately 155 days

    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.

Secondary outcomes

  1. Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)

    Time frame: Up to approximately 15 days

    SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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