PsoriasisPhase 1NCT00848055
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis
A Phase 1 study testing AbGn168 intravenous infusion and AbGn168 subcutaneous injection in people with Psoriasis, run by Boehringer Ingelheim at 7 sites in 2 countries.
Trial summary
The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- AbGn168 intravenous infusion and AbGn168 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2008to Oct 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.
Who cannot join
- Recent use of biologic agents, oral psoriasis medications or phototherapy
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
1240.1.04 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1240.1.05 Boehringer Ingelheim Investigational Site
Boise, Idaho
1240.1.02 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1240.1.03 Boehringer Ingelheim Investigational Site
Dallas, Texas
1240.1.06 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1240.1.01 Boehringer Ingelheim Investigational Site
New York, New York
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis
The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis
- Conditions
- Psoriasis
- Being tested
- AbGn168 intravenous infusion, AbGn168 subcutaneous injection
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 intravenous infusionDrug
single dose intravenous infusion
AbGn168 subcutaneous injectionDrug
single dose subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | AbGn168 cohort 1 Receives: Drug: AbGn168 intravenous infusion |
| arm 2 | Experimental | AbGn168 cohort 2 Receives: Drug: AbGn168 intravenous infusion |
| arm 3 | Experimental | AbGn168 cohort 3 Receives: Drug: AbGn168 intravenous infusion |
| arm 4 | Experimental | AbGn168 cohort 4 Receives: Drug: AbGn168 intravenous infusion |
| arm 5 | Experimental | AbGn168 cohort 5 Receives: Drug: AbGn168 intravenous infusion |
| arm 6 | Experimental | AbGn168 cohort 6 Receives: Drug: AbGn168 intravenous infusion |
| arm 7 | Experimental | AbGn168 cohort 7 Receives: Drug: AbGn168 intravenous infusion |
| arm 8 | Experimental | AbGn168 cohort 8 Receives: Drug: AbGn168 subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
Measured: Baseline, on treatment,and at end of study
Secondary outcomes (1)
Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy
Measured: Baseline and on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848055
- Sponsor's protocol ID
- 1240.1
- Status last verified
- Oct 2013
- First submitted
- 18 Feb 2009
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00848055
- Acronym / sponsor ID
- 1240.1
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (actual)
- First posted
- 20 Feb 2009 (estimated)
- 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 general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 1 |
| arm 2 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 2 |
| arm 3 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 3 |
| arm 4 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 4 |
| arm 5 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 5 |
| arm 6 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 6 |
| arm 7 | Experimental | Drug: AbGn168 intravenous infusionAbGn168 cohort 7 |
| arm 8 | Experimental | Drug: AbGn168 subcutaneous injectionAbGn168 cohort 8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.
Key exclusion criteria (1 listed)
- Recent use of biologic agents, oral psoriasis medications or phototherapy
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 |
|---|---|---|
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 2 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 3 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 1 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 4 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 5 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 6 |
| AbGn168 intravenous infusionsingle dose intravenous infusion | Drug | arm 7 |
| AbGn168 subcutaneous injectionsingle dose subcutaneous injection | Drug | arm 8 |
Primary outcome
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events
Time frame: Baseline, on treatment,and at end of study
1 secondary outcome
Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy
Time frame: Baseline and on treatment
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 1 Nov 2013.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
7 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 AbGn168 intravenous infusion and AbGn168 subcutaneous injection in people with Psoriasis, run by Boehringer Ingelheim at 7 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 1 inclusion and 1 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events (time frame: Baseline, on treatment,and at end of study). 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 1 Nov 2013.