Arthritis, PsoriaticPhase 1NCT00787137
Single Dose PG102 in Patients With Active Psoriatic Arthritis
A Phase 1 study testing PG102 in people with Arthritis, Psoriatic, run by PanGenetics UK Limited at 1 site in Serbia.
Trial summary
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- PG102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSerbia
- Study dates
- Dec 2008to May 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
- Plaque psoriasis for at least 6 months prior to study enrollment
Who cannot join
- Clinically significant psoriasis flare
- Unstable doses of pain relief medication
- Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
- Treatment with any biologic therapy
- Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
- Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
Show all 12Show fewer
- Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
- Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
- Currently smoking ≥ 10 cigarettes per day or equivalent
- Active tuberculosis or other infection
- Current or previous malignancies
- Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.
- Conditions
- Arthritis, Psoriatic
- Being tested
- PG102, Placebo comparator
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG102Drug
Also called Anti-CD40 monoclonal antibody
A single intravenous infusion
Placebo comparatorDrug
Phosphate-buffered saline
| Study group | Role | What they receive |
|---|---|---|
| PG102 0.3 mg/kg | Experimental | Lowest dose PG102 Receives: Drug: PG102 |
| PG102 1 mg/kg | Experimental | Second dose PG102 Receives: Drug: PG102 |
| Placebo (phosphate-buffered saline) | Placebo comparator | Control Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Reported Adverse Events
This was an exploratory study and all safety endpoints were considered.
Measured: Three months
The Percentage of Participants With Adverse Events
Measured: Three months
The Number of Episodes of Change in Vital Signs
Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 \& 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.
Measured: Three months
The Number of Episodes of Change in Electrocardiogram
Episodes of clinically significant change in 12-lead electrocardiogram predose,1 \& 4 hours and 1 \& 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.
Measured: Three months
The Number of Episodes of Change From Screening in Laboratory Assessments
Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionMay 2010
Why it stopped: poor recruitment
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 Arthritis, PsoriaticStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- PanGenetics UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nemanja Damjanov, MD PhD, Principal investigator, Institute of Rheumatology, Belgrade, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787137
- Sponsor's protocol ID
- PG102-01
- Other IDs
- 2007-001017-42
- Status last verified
- Oct 2010
- First submitted
- 6 Nov 2008
- Last updated
- 26 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00787137
- Acronym / sponsor ID
- PG102-01
- Conditions
- Arthritis, Psoriatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PanGenetics UK LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 15 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PG102 0.3 mg/kg | Experimental | Drug: PG102Lowest dose PG102 |
| PG102 1 mg/kg | Experimental | Drug: PG102Second dose PG102 |
| Placebo (phosphate-buffered saline) | Placebo comparator | Drug: Placebo comparatorControl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
- Plaque psoriasis for at least 6 months prior to study enrollment
Key exclusion criteria (12 listed)
- Clinically significant psoriasis flare
- Unstable doses of pain relief medication
- Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
- Treatment with any biologic therapy
- Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
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 |
|---|---|---|
| PG102Also: Anti-CD40 monoclonal antibodyA single intravenous infusion | Drug | PG102 0.3 mg/kg, PG102 1 mg/kg |
| Placebo comparatorPhosphate-buffered saline | Drug | Placebo (phosphate-buffered saline) |
Primary outcome
The Number of Reported Adverse Events
Time frame: Three months
This was an exploratory study and all safety endpoints were considered.
The Percentage of Participants With Adverse Events
Time frame: Three months
The Number of Episodes of Change in Vital Signs
Time frame: Three months
Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 \& 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.
The Number of Episodes of Change in Electrocardiogram
Time frame: Three months
Episodes of clinically significant change in 12-lead electrocardiogram predose,1 \& 4 hours and 1 \& 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.
The Number of Episodes of Change From Screening in Laboratory Assessments
Time frame: Three months
Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nemanja Damjanov, MD PhD principal investigator
Institute of Rheumatology, Belgrade, Serbia
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 PG102 in people with Arthritis, Psoriatic, run by PanGenetics UK Limited at 1 site in Serbia.
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 2 inclusion and 12 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 Oct 2010. 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 Serbia. 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 15 Oct 2010). 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?
The Number of Reported Adverse Events (time frame: Three months). The study lists 5 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 Oct 2010.