Arthritis, PsoriaticPhase 1NCT05083078
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
A Phase 1 study testing Guselkumab and Risankizumab in people with Arthritis, Psoriatic and Healthy, run by Janssen Research & Development, LLC at 1 site in Austria.
Trial summary
The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Psoriatic, Healthy
- What is being tested?
- Guselkumab and Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- 4 Nov 2021to 1 Jul 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1:
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration
- Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive)
- Parts 2 and 3:
- Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening
- Have active plaque psoriasis
Who cannot join
- Part 1:
- History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances
- Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration
- Parts 2 and 3:
- History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis
The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).
- Conditions
- Arthritis, Psoriatic, Healthy
- Being tested
- Guselkumab, Risankizumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called Tremfya, CNTO1959
Guselkumab will be administered subcutaneously.
RisankizumabDrug
Also called Skyrizi
Risankizumab will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Healthy Participants-Coadministration | Experimental | Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. Receives: Drug: Guselkumab; Drug: Risankizumab |
| Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration | Experimental | Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. Receives: Drug: Guselkumab; Drug: Risankizumab |
| Part 3: PsA Participants-Separate Administration | Experimental | Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. Receives: Drug: Guselkumab; Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
Skin tissue versus serum concentration ratio will be summarized.
Measured: Up to Week 12
Part 1: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Measured: Up to Week 8
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Measured: Up to Week 4
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
Synovial tissue versus serum concentration ratio will be summarized.
Measured: Up to Week 12
Secondary outcomes (8)
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab
Cmax is defined as maximum observed serum concentration.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab
Tmax is defined as time to reach maximum observed serum concentration.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab
AUC(0-last) is defined as area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Terminal Half-life (T1/2)
T1/2 is defined as terminal half-life.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab
CL/F is defined as apparent total systemic clearance after extravascular administration.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab
Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab
The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method.
Measured: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start4 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: The study was stopped due to unanticipated feasibility constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083078
- Sponsor's protocol ID
- CR109047
- Other IDs
- 2021-000896-35, CNTO1959PSA1001
- Status last verified
- Jul 2022
- First submitted
- 11 Oct 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05083078
- Acronym / sponsor ID
- CR109047
- Conditions
- Arthritis, Psoriatic, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to unanticipated feasibility constraints.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Oct 2021 (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 purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Healthy Participants-Coadministration | Experimental | Drug: Guselkumab, Drug: RisankizumabHealthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1. |
| Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration | Experimental | Drug: Guselkumab, Drug: RisankizumabParticipants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29. |
| Part 3: PsA Participants-Separate Administration | Experimental | Drug: Guselkumab, Drug: RisankizumabParticipants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration
- Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive)
- Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening
- Have active plaque psoriasis
Key exclusion criteria (6 listed)
- History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances
- Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration
- History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
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 |
|---|---|---|
| GuselkumabAlso: Tremfya, CNTO1959Guselkumab will be administered subcutaneously. | Drug | Part 1: Healthy Participants-Coadministration, Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration, Part 3: PsA Participants-Separate Administration |
| RisankizumabAlso: SkyriziRisankizumab will be administered subcutaneously. | Drug | Part 1: Healthy Participants-Coadministration, Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration, Part 3: PsA Participants-Separate Administration |
Primary outcome
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
Time frame: Up to Week 12
Skin tissue versus serum concentration ratio will be summarized.
Part 1: Colon Tissue versus Serum Concentration Ratio
Time frame: Up to Week 8
Colon tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
Time frame: Up to Week 4
Colon tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
Time frame: Up to Week 12
Synovial tissue versus serum concentration ratio will be summarized.
8 secondary outcomes
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Terminal Half-life (T1/2)
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Results and safety
The study was stopped early (reason given: The study was stopped due to unanticipated feasibility constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Guselkumab and Risankizumab in people with Arthritis, Psoriatic and Healthy, run by Janssen Research & Development, LLC at 1 site in Austria.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Jul 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 Austria. 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 was stopped early (reason given: The study was stopped due to unanticipated feasibility constraints.). Results are not available in the source record.
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?
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio (time frame: Up to Week 12). The study lists 4 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 26 Jul 2022.