Healthy VolunteersPhase 1NCT05274087
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 7 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) is >= 18.0 to <= 30.0 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
- Keywords
- Risankizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called SKYRIZI
Subcutaneous autoinjector
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Drug: Risankizumab |
| Group 2 | Experimental | Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3. Receives: Drug: Risankizumab |
| Group 3 | Experimental | Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to approximately 155 days
Secondary outcomes (1)
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).
Measured: Up to approximately 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start15 Sep 2020
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274087
- Sponsor's protocol ID
- M20-200
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05274087
- Acronym / sponsor ID
- M20-200
- Conditions
- Healthy Volunteers
- Keywords
- Risankizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: RisankizumabParticipants 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. |
| Group 2 | Experimental | Drug: RisankizumabParticipants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3. |
| Group 3 | Experimental | Drug: RisankizumabParticipants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) is >= 18.0 to <= 30.0 kg/m2.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisankizumabAlso: SKYRIZISubcutaneous autoinjector | Drug | Group 1, Group 2, Group 3 |
Primary outcome
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).
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.
1 secondary outcome
Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)
Time frame: Up to approximately 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Injection Site Pain Assessed Using Visual Analog Scale (time frame: Up to approximately 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.