Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis

A Phase 1 study testing Rozibafusp Alfa in people with Rheumatoid Arthritis, run by Amgen at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Rozibafusp Alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 4 sitesin 2 countries
Study dates: 14 Aug 2017to 12 Jun 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body Mass Index: 18-35 kg/m^2
Diagnosed with RA (disease duration of at least 6 months)
Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)
Immunizations up to date
Willing to use highly effective contraception during treatment and through end-of-study

Who cannot join

Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension)
Malignancy within 5 years
Presence of serious infection, recurrent/chronic infections
Class IV RA according to American College of Rheumatology/ (ACR) revised response criteria
Diagnosed with Felty's syndrome
Known or suspected sensitivity to mammalian cell-derived products

Show all 9Show fewer

History of alcohol and/or substance abuse within the last 12 months
Receipt of rituximab at any time in the past
Evidence of renal disease

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Pinnacle Research Group LLC
Anniston, Alabama, 36207
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635

Other trials in United States

Germany1 site

Charite Research Organisation GmbH
Berlin, 10117

Other trials in Germany

About this study

Official title: A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).

Conditions: Rheumatoid Arthritis
Being tested: Rozibafusp Alfa, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rozibafusp AlfaDrug
Also called AMG 570
Administered by subcutaneous injection once every 2 weeks.
PlaceboDrug
Administered by subcutaneous injection once every 2 weeks.

Study groups in NCT03156023
Study group	Role	What they receive
Rozibafusp Alfa	Experimental	Participants will receive rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Rozibafusp alfa doses will range from 70 to 420 mg. Escalation to a higher dose cohort will be contingent on a review indicating that the previous dose regimen has been found to demonstrate an acceptable safety and tolerability profile at a dose level review meeting (DLRM). Receives: Drug: Rozibafusp Alfa
Placebo	Placebo comparator	Participants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment.
AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death.
A serious adverse event is defined as an AE that met at least 1 of the following serious criteria:
- fatal;
- life threatening;
- required in patient hospitalization or prolongation of existing hospitalization;
- resulted in persistent or significant disability/incapacity;
- congenital anomaly/birth defect;
- other medically important serious event. The investigator assessed whether each AE was related to study drug.
Measured: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).

Secondary outcomes (7)

Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa
Measured: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa
Measured: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa
Measured: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa
Measured: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Terminal Half-life of Rozibafusp Alfa
Measured: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Accumulation Ratio of AUCtau
Accumulation ratio is the ratio of AUCtau after the last dosing interval (week 10) divided by AUCtau after the first dosing interval (day 1).
Measured: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose
Accumulation Ratio of Cmax
Accumulation ratio is the ratio of Cmax after the last dosing interval (week 10) divided by Cmax after the first dosing interval (day 1).
Measured: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201712 Jun 2020

First posted16 May 2017
Study start14 Aug 2017
Primary completion17 Oct 2019
Study completion12 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by AmgenThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03156023
Sponsor's protocol ID: 20150196
Other IDs: 2017-000337-31, 2017
Status last verified: May 2024
First submitted: 15 May 2017
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.
PubMed 37150935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT03156023
Acronym / sponsor ID: 20150196
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 14 Aug 2017 (actual)
Primary completion: 17 Oct 2019 (actual)
Study completion: 12 Jun 2020 (actual)
First posted: 16 May 2017 (actual)
Results: Posted 3 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Rozibafusp Alfa	Experimental	Drug: Rozibafusp AlfaParticipants will receive rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Rozibafusp alfa doses will range from 70 to 420 mg. Escalation to a higher dose cohort will be contingent on a review indicating that the previous dose regimen has been found to demonstrate an acceptable safety and tolerability profile at a dose level review meeting (DLRM).
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Body Mass Index: 18-35 kg/m^2
Diagnosed with RA (disease duration of at least 6 months)
Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)
Immunizations up to date
Willing to use highly effective contraception during treatment and through end-of-study

Key exclusion criteria (9 listed)

Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension)
Malignancy within 5 years
Presence of serious infection, recurrent/chronic infections
Class IV RA according to American College of Rheumatology/ (ACR) revised response criteria
Diagnosed with Felty's syndrome

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
Rozibafusp AlfaAlso: AMG 570Administered by subcutaneous injection once every 2 weeks.	Drug	Rozibafusp Alfa
PlaceboAdministered by subcutaneous injection once every 2 weeks.	Drug	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events
Time frame: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal; * life threatening; * required in patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. The investigator assessed whether each AE was related to study drug.

7 secondary outcomes

Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa
Time frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa
Time frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa
Time frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa
Time frame: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Terminal Half-life of Rozibafusp Alfa
Time frame: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.
Accumulation Ratio of AUCtau
Time frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose
Accumulation Ratio of Cmax
Time frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose

Results and safety

Results posted to the registry on 3 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	8	7
Rozibafusp Alfa 70 mg	7	7
Rozibafusp Alfa 140 mg	6	4
Rozibafusp Alfa 210 mg	6	5
Rozibafusp Alfa 420 mg	7	5

Primary outcome: Number of Participants With Treatment-emergent Adverse Events

Time frame: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).. Count of participants. Unit: Participants

Measure	Placebo n = 8	Rozibafusp Alfa 70 mg n = 7	Rozibafusp Alfa 140 mg n = 6	Rozibafusp Alfa 210 mg n = 6	Rozibafusp Alfa 420 mg n = 7
Any treatment-emergent adverse event (TEAE)	7	6	6	6	7
TEAE Grade ≥ 2	4	5	3	4	6
TEAE Grade ≥ 3	0	1	1	0	0
TEAE Grade ≥ 4	0	0	0	0	0
Serious adverse events	0	1	1	0	0
TEAE leading to discontinuation of study drug	0	0	0	0	0
Severe adverse events	0	1	1	0	0
Life-threatening adverse events	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 dose of rozibafusp alfa or placebo.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Rozibafusp Alfa 70 mg	1 of 7 (14.3%)	6 of 7 (85.7%)	0 of 7
Rozibafusp Alfa 140 mg	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
Rozibafusp Alfa 210 mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Rozibafusp Alfa 420 mg	0 of 7 (0%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37150935Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Related trials for Rheumatoid Arthritis

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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.

MD study director

Amgen

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rozibafusp Alfa in people with Rheumatoid Arthritis, run by Amgen at 4 sites in 2 countries.

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 5 inclusion and 9 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Germany. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-emergent Adverse Events (time frame: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03156023, which also lists 1 linked publication.

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 14 May 2024.