PsoriasisPhase 2NCT04776629
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
A Phase 2 study testing Orticumab in people with Psoriasis and Inflammation, run by Abcentra at 13 sites in United States.
Trial summary
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Psoriasis, Inflammation, Coronary Artery Disease
- What is being tested?
- Orticumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Jun 2021to 11 Nov 2022
- Phase
- Phase 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable/chronic plaque psoriasis with PASI score of ≥ 12 AND involving ≥ 10% of the subject's BSA.- ≥ 30 years of age at time of consent.
- BMI ≥ 30 kg/m2
- LDL ≥ 100 mg/dL at Screening.
- All females must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test prior to dosing.
Who cannot join
- Subjects are excluded from the study if any of the following criteria are met:
- Past use of orticumab.
- Any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Scalp, palmar or plantar psoriasis only, at Screening or Baseline.
- Have evidence of skin conditions (e.g., eczema) at the time of Screening or Baseline visit that would interfere with theevaluation of psoriasis.
- Newly discovered Type 2 diabetes mellitus (T2DM)
Show all 18Show fewer
- Moderate or high-intensity statin use or new use of a low-intensity statin therapy.
- No use of anti-coagulating or anti-thrombotic agents.
- Poorly controlled hypertension
- Use of an IL-23 blocker in the past 180 days, an IL-17 blocker in the past 16 weeks, or a TNF blocker in the past 12 weeks.
- Use of methotrexate, cyclosporine, or apremilast in the past 4 weeks.
- History of hypersensitivity or allergies to any contents in the orticumab formulation.
- A history of any clinically important abnormalities in cardiac rhythm or conduction.
- A history of prolonged QT intervals or a family history of long QT-syndrome at Screening.
- A history of first, second or third-degree atrioventricular (AV) block, or AV dissociation.
- A history of complete bundle branch block.
- Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to Screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within 6 months prior to Screening or who are due to undergo these procedures at the time of Screening.
- Severe congestive heart failure (NYHA III or IV).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Las Vegas Clinical Trials
Las Vegas, Nevada, 89030
Excel Clinical Research
Las Vegas, Nevada, 89109
SMS Clinical Research
Mesquite, Texas, 75149
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Derm Institute & Skin Care Ctr., Inc.
Santa Monica, California, 90404
CCT- Research at the center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260
CCT Research - Springville Dermatology
Springville, Utah, 84663
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 85260
Orange County Research Center
Tustin, California, 92780
Blue Coast Research Center
Vista, California, 92083
Center for Clinical Studies, LTD.LLP
Webster, Texas, 77598
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-controlled Proof-of-Activity Study With Orticumab in Subjects With Moderate-to-Severe Psoriasis and Cardiometabolic Risk Factors
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.
Read the detailed description
This randomized, double-blind, study is designed to compare the effect of orticumab against placebo in subjects with moderate to severe psoriasis and cardiometabolic risk factors. A total of 75 subjects will be randomized in a double-blind fashion to receive intravenous (IV) infusions either of orticumab or placebo for up to 78 days.
Participants will be enrolled into one of the two groups: active treatment or placebo. Subjects will be randomized in a 2:1 ratio, orticumab to placebo and receive up to 11 weeks of treatment.
Planned treatments are weekly x 4 , then monthly x 2 . The Internal Safety Review Committee (ISRC) will review the blinded safety data after the first subject completes the first dose (Day 1), the first five subjects complete the first dose (Day 1), and the first ten subjects complete the first dose (Day 1). The IRSC will review all adverse reactions to all administered doses at these times.
- Being tested
- Orticumab, Placebo
- Medical subject headings
- Psoriasis, Inflammation, Coronary Artery Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrticumabDrug
Also called MLDL1278a; BI-204; Anti-oxLDL Antibody
A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
PlaceboDrug
Placebo for orticumab, containing all components of formulation except the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. Receives: Drug: Orticumab |
| Placebo | Placebo comparator | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Measured: 106 days (Week 15)
Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score
Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (>=) 2 Point Improvement at Week 15 on the sIGA scale
Measured: 106 days (Week 15)
Secondary outcomes (5)
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Measured: Weeks 1, 3, 7, and 11
Percentage of Participants Achieving PASI75 and PASI50
PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score
Measured: Weeks 1, 3, 7, and 11
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
Measured: Weeks 1, 3, 7, 11, 15
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: Weeks 3, 7, 11, 15
Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score
The Itch NRS is a self-administered subject reported outcome questionnaire that is completed during protocol specified clinic visits. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to psoriasis in the past 24 h on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'.
Measured: Weeks 3 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start30 Jun 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abcentra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776629
- Sponsor's protocol ID
- Ort-2020-01
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2021
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Farina CJ, Davidson MH, Shah PK, Stark C, Lu W, Shirodaria C, Wright T, Antoniades CA, Nilsson J, Mehta NN. Inhibition of oxidized low-density lipoprotein with orticumab inhibits coronary inflammation and reduces residual inflammatory risk in psoriasis: a pilot randomized, double-blind placebo-controlled trial. Cardiovasc Res. 2024 May 29;120(7):678-680. doi: 10.1093/cvr/cvae057. No abstract available.
PubMed 38523341
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-controlled Proof-of-Activity Study With Orticumab in Subjects With Moderate-to-Severe Psoriasis and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT04776629
- Acronym / sponsor ID
- Ort-2020-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AbcentraIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.
Detailed description
This randomized, double-blind, study is designed to compare the effect of orticumab against placebo in subjects with moderate to severe psoriasis and cardiometabolic risk factors. A total of 75 subjects will be randomized in a double-blind fashion to receive intravenous (IV) infusions either of orticumab or placebo for up to 78 days.
Participants will be enrolled into one of the two groups: active treatment or placebo. Subjects will be randomized in a 2:1 ratio, orticumab to placebo and receive up to 11 weeks of treatment.
Planned treatments are weekly x 4 , then monthly x 2 . The Internal Safety Review Committee (ISRC) will review the blinded safety data after the first subject completes the first dose (Day 1), the first five subjects complete the first dose (Day 1), and the first ten subjects complete the first dose (Day 1). The IRSC will review all adverse reactions to all administered doses at these times.
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 |
|---|---|---|
| Active Treatment | Active comparator | Drug: OrticumabDosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
| Placebo | Placebo comparator | Drug: PlaceboDosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable/chronic plaque psoriasis with PASI score of ≥ 12 AND involving ≥ 10% of the subject's BSA.- ≥ 30 years of age at time of consent.
- BMI ≥ 30 kg/m2
- LDL ≥ 100 mg/dL at Screening.
- All females must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test prior to dosing.
Key exclusion criteria (18 listed)
- Past use of orticumab.
- Any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Scalp, palmar or plantar psoriasis only, at Screening or Baseline.
- Have evidence of skin conditions (e.g., eczema) at the time of Screening or Baseline visit that would interfere with theevaluation of psoriasis.
- Newly discovered Type 2 diabetes mellitus (T2DM)
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 |
|---|---|---|
| OrticumabAlso: MLDL1278a; BI-204; Anti-oxLDL AntibodyA human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope | Drug | Active Treatment |
| PlaceboPlacebo for orticumab, containing all components of formulation except the active ingredient | Drug | Placebo |
Primary outcome
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Time frame: 106 days (Week 15)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score
Time frame: 106 days (Week 15)
Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (>=) 2 Point Improvement at Week 15 on the sIGA scale
5 secondary outcomes
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Time frame: Weeks 1, 3, 7, and 11
Percentage of Participants Achieving PASI75 and PASI50
Time frame: Weeks 1, 3, 7, and 11
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Time frame: Weeks 1, 3, 7, 11, 15
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Weeks 3, 7, 11, 15
Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score
Time frame: Weeks 3 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38523341Farina CJ, Davidson MH, Shah PK, Stark C, Lu W, Shirodaria C, Wright T, Antoniades CA, Nilsson J, Mehta NN. Inhibition of oxidized low-density lipoprotein with orticumab inhibits coronary inflammation and reduces residual inflammatory risk in psoriasis: a pilot randomized, double-blind placebo-controlled trial. Cardiovasc Res. 2024 May 29;120(7):678-680. doi: 10.1093/cvr/cvae057. No abstract available.
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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.
Joel Neutel, MD principal investigator
Orange County Research Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orticumab in people with Psoriasis and Inflammation, run by Abcentra at 13 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 4 inclusion and 18 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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 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 11 May 2026). 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?
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) (time frame: 106 days (Week 15)). The study lists 2 primary outcomes in all. 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 NCT04776629, 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 11 May 2026.