Plaque PsoriasisPhase 1/2NCT02243787
Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
A Phase 1/2 study testing COVA322 in people with Plaque Psoriasis, run by Covagen at 2 sites in Germany.
Trial summary
This study is a randomised, double-blind, placebo-controlled, sequential, ascending single-dose, parallel group study to evaluate safety, tolerability, biological activity, and systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A) antibody fusion protein) in patients with stable… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- COVA322
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2014to Sep 2015
- Phase
- Phase 1/2
- 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
- Male or female subjects of any ethnic origin; women must be of non-childbearing potential
- Aged between 18 to 65 yrs inclusive
- Body weight of ≥ 40 kg and body mass index between 19 - 32 kg/m2 inclusive
- Established diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criteria:
- Psoriasis involving ≥ 10% of body surface area
- Requirement of phototherapy or systemic therapy
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- Psoriasis Area and Severity Index (PASI) score of ≥ 10
- Physician"s Global Assessment (PGA) score of ≥ 3
- stable disease
Who cannot join
- History of clinically relevant allergies or idiosyncrasies to COVA322
- Any history of clinically significant drug hypersensitivity following any therapy with a therapeutical biologic, or asthma, urticaria, or other allergic diathesis
- Clinically significant flare of psoriasis during the 12 weeks before randomization
- Current evidence of non-plaque forms of psoriasis
- Currently evidence of drug-induced psoriasis
- Evidence of any serious systemic or local infection within 3 months before screening
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- Evidence of subclinical/latent tuberculosis infection
- History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
- History or current evidence of autoimmune diseases other than psoriasis
- Women of child-bearing potential
- Recent previous exposure to systemic psoriasis treatments, including anti-TNF-α therapies, immunosuppressive agents such as cyclosporine, mycophenolate, or tacrolimus, and other medications affecting the immune function
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 2.5 times the upper limit of normal (ULN) at screening
- Serum creatinine level ≥ 1.5 times the ULN at screening
- Positive results in any of the virology tests for HIV-Ab, hepatitis C-virus antibody (HCV-Ab) and hepatitis B-virus surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité research organisation
Berlin
SCIderm and Clinical Trial Center North
Hamburg
About this study
Official title: A Randomised, Double-blind, Sequential, Ascending Single-dose Study to Evaluate Safety, Tolerability, Biological Activity, and Systemic Exposure of COVA322, a Bispecific TNF-α / IL-17A Antibody Fusion Protein, in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
This study is a randomised, double-blind, placebo-controlled, sequential, ascending single-dose, parallel group study to evaluate safety, tolerability, biological activity, and systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A) antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis. Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v. infusion, followed by 12 weeks of evaluation.
- Conditions
- Plaque Psoriasis
- Being tested
- COVA322, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVA322Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| COVA322 | Experimental | single i.v. infusion Receives: Drug: COVA322 |
| Placebo | Placebo comparator | single i.v. infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events as a Measure of Safety and Tolerability
The safety and tolerability of COVA322 will be assessed by monitoring the occurrence of local and systemic adverse events or abnormalities as identified by physical examinations, safety lab, vital parameters, ECG and immune response/antibodies to COVA322.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
Why it stopped: Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristian Reich, Prof. Dr. med, Principal investigator, Sciderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243787
- Sponsor's protocol ID
- COVA322-SAD-Psoriasis-001
- Status last verified
- Feb 2016
- First submitted
- 9 Sep 2014
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silacci M, Lembke W, Woods R, Attinger-Toller I, Baenziger-Tobler N, Batey S, Santimaria R, von der Bey U, Koenig-Friedrich S, Zha W, Schlereth B, Locher M, Bertschinger J, Grabulovski D. Discovery and characterization of COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases. MAbs. 2016;8(1):141-9. doi: 10.1080/19420862.2015.1093266. Epub 2015 Sep 22.
PubMed 26390837
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Sequential, Ascending Single-dose Study to Evaluate Safety, Tolerability, Biological Activity, and Systemic Exposure of COVA322, a Bispecific TNF-α / IL-17A Antibody Fusion Protein, in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02243787
- Acronym / sponsor ID
- COVA322-SAD-Psoriasis-001
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CovagenIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- First posted
- 18 Sep 2014 (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.
This study is a randomised, double-blind, placebo-controlled, sequential, ascending single-dose, parallel group study to evaluate safety, tolerability, biological activity, and systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A) antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis. Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v. infusion, followed by 12 weeks of evaluation.
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 |
|---|---|---|
| COVA322 | Experimental | Drug: COVA322single i.v. infusion |
| Placebo | Placebo comparator | Other: Placebosingle i.v. infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects of any ethnic origin; women must be of non-childbearing potential
- Aged between 18 to 65 yrs inclusive
- Body weight of ≥ 40 kg and body mass index between 19 - 32 kg/m2 inclusive
- Established diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criteria:
- Psoriasis involving ≥ 10% of body surface area
Key exclusion criteria (14 listed)
- History of clinically relevant allergies or idiosyncrasies to COVA322
- Any history of clinically significant drug hypersensitivity following any therapy with a therapeutical biologic, or asthma, urticaria, or other allergic diathesis
- Clinically significant flare of psoriasis during the 12 weeks before randomization
- Current evidence of non-plaque forms of psoriasis
- Currently evidence of drug-induced psoriasis
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 |
|---|---|---|
| COVA322 | Drug | COVA322 |
| Placebo | Other | Placebo |
Primary outcome
Occurrence of Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 12 weeks
The safety and tolerability of COVA322 will be assessed by monitoring the occurrence of local and systemic adverse events or abnormalities as identified by physical examinations, safety lab, vital parameters, ECG and immune response/antibodies to COVA322.
Results and safety
The study was stopped early (reason given: Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Derived from this study: PubMed 26390837Silacci M, Lembke W, Woods R, Attinger-Toller I, Baenziger-Tobler N, Batey S, Santimaria R, von der Bey U, Koenig-Friedrich S, Zha W, Schlereth B, Locher M, Bertschinger J, Grabulovski D. Discovery and characterization of COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases. MAbs. 2016;8(1):141-9. doi: 10.1080/19420862.2015.1093266. Epub 2015 Sep 22.
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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.
Kristian Reich, Prof. Dr. med principal investigator
Sciderm GmbH
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 COVA322 in people with Plaque Psoriasis, run by Covagen at 2 sites in Germany.
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 9 inclusion and 14 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 1 Mar 2016. 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 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 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?
The study was stopped early (reason given: Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.). 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?
Occurrence of Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 12 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 NCT02243787, 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 1 Mar 2016.