PsoriasisPhase 1/2NCT00954915

Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis

A Phase 1/2 study testing teplizumab in people with Psoriasis, run by MacroGenics at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to determine whether teplizumab is safe when administered subcutaneously (by needle under the skin) in subjects with psoriasis. The study will also evaluate how long teplizumab stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Psoriasis
What is being tested?: teplizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 2 sitesUnited States
Study dates: Dec 2009to Jul 2010
Phase: Phase 1/2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% Body Surface Area (BSA).
Baseline LS-PGA score of moderate or greater severity.
Weight <= 125 kg (276 lb) and a BSA <= 2.5 m^2.

Who cannot join

Clinically significant flare of psoriasis during the 12 weeks before enrollment.
Guttate, erythrodermic, palmoplantar, or pustular (von Zumbusch) psoriasis
Orally administered systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks before enrollment.
Prior administration of a biologic agent/monoclonal antibody within 12 weeks before enrollment or 5 half-lives of the agent, whichever is greater.
Prior otelixizumab, OKT®3, or teplizumab.
Treatment within the last 30 days with a non-biologic drug or device that has not received regulatory approval for any indication at the time of study entry or are unwilling to forgo experimental treatment other than teplizumab during this study.

Show all 17Show fewer

Treatment with live vaccine within 8 weeks before enrollment or during study; vaccination with an antigen or killed organism during the study, within 8 weeks before enrollment, or 8 weeks after dosing.
Evidence of active infection.
Positive IgM test for hepatitis A.
History of or positive test for hepatitis B, C, or D.
History of or positive test for HIV.
Are immunocompromised, have had recent or current serious systemic or local infection, clinical or radiological evidence of active tuberculosis, or evidence of latent TB infection.
History of chronic liver disease, peripheral vascular disease, cerebrovascular disease, cardiovascular disease, or epilepsy.
Current serious or unstable illnesses or allergies.
Clinically significant laboratory abnormalities.
Presence of serological reactivity to teplizumab (in subjects previously treated with therapeutic antibodies).
Clinically significant ECG abnormalities.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase 2a, Open Label, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Teplizumab in Adults With Moderate or More Severe Psoriasis

Read the detailed description

This study will test the hypotheses that therapeutic modulation of T-cell function by teplizumab is well tolerated in subjects with moderate or more severe psoriasis, and that this treatment ameliorates the immunopathology of psoriasis. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration for 6 days. Once the SC maximum tolerated dose is identified, this dose will be administered to a cohort of subject by intravenous for comparison of PK and PD.

Conditions: Psoriasis
Being tested: teplizumab
Keywords: chronic plaque psoriasis, psoriatic arthritis
Medical subject headings: Psoriasis, Arthritis, Psoriatic

What participants receive

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

teplizumabBiological
Also called MGA031
Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.

Study groups in NCT00954915
Study group	Role	What they receive
teplizumab	Experimental	Anti CD-3 monoclonal antibody Receives: Biological: teplizumab

What is being measured

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

Adverse Events (AE)
Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.
Measured: Day 0 through Day 84

Secondary outcomes (4)

Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)
The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.
Measured: Day 0, 14, 28, 63 and 84
Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.
Measured: Day 0, 14, 28, 63 and 84
Physician's Global Assessment (PGA)
The PGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.
Measured: Day 0, 14, 28, 63 and 84
Teplizumab Blood Levels
Measured: Day 0 through Day 84

Timeline

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

Dec 2009Jul 2010

First posted7 Aug 2009 (estimated)
Study startDec 2009
Primary completionJul 2010
Study completionJul 2010

Why it stopped: Injection site reaction met protocol-defined stopping criteria.

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.
Other trials for PsoriasisStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00954915
Sponsor's protocol ID: CP-MGA031-04
Status last verified: Jan 2022
First submitted: 4 Aug 2009
Last updated: 10 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Open Label, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Teplizumab in Adults With Moderate or More Severe Psoriasis
ClinicalTrials.gov ID: NCT00954915
Acronym / sponsor ID: CP-MGA031-04
Conditions: Psoriasis
Keywords: chronic plaque psoriasis, psoriatic arthritis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Injection site reaction met protocol-defined stopping criteria.
Enrolment: 1 participants (actual)
Lead sponsor: MacroGenicsIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Dec 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 7 Aug 2009 (estimated)
Results: Posted 19 Apr 2012

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
teplizumab	Experimental	Biological: teplizumabAnti CD-3 monoclonal antibody

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% Body Surface Area (BSA).
Baseline LS-PGA score of moderate or greater severity.
Weight <= 125 kg (276 lb) and a BSA <= 2.5 m^2.

Key exclusion criteria (17 listed)

Clinically significant flare of psoriasis during the 12 weeks before enrollment.
Guttate, erythrodermic, palmoplantar, or pustular (von Zumbusch) psoriasis
Orally administered systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks before enrollment.
Prior administration of a biologic agent/monoclonal antibody within 12 weeks before enrollment or 5 half-lives of the agent, whichever is greater.
Prior otelixizumab, OKT®3, or teplizumab.

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
teplizumabAlso: MGA031Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.	Biological	teplizumab

Primary outcome

Adverse Events (AE)
Time frame: Day 0 through Day 84
Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.

4 secondary outcomes

Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)
Time frame: Day 0, 14, 28, 63 and 84
Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)
Time frame: Day 0, 14, 28, 63 and 84
Physician's Global Assessment (PGA)
Time frame: Day 0, 14, 28, 63 and 84
Teplizumab Blood Levels
Time frame: Day 0 through Day 84

Results and safety

Results posted to the registry on 19 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teplizumab	1	1

Primary outcome: Adverse Events (AE)

Time frame: Day 0 through Day 84. Number. Unit: Participants

Measure	Teplizumab n = 1
Value	1

Population analysed: One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teplizumab	0 of 1 (0%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated, with only 1 subject enrolled, due to meeting the study criteria for discontinuation regarding local or regional injection site reactions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing teplizumab in people with Psoriasis, run by MacroGenics at 2 sites 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 3 inclusion and 17 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Apr 2012). 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?

Adverse Events (AE) (time frame: Day 0 through Day 84). 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 NCT00954915.

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 Feb 2022.