PsoriasisPhase 1NCT01836939
Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis
A Phase 1 study testing TSO 2500 and TSO 7500 in people with Psoriasis, run by Mark Lebwohl at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- TSO 2500 and TSO 7500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, 18 to 75 years old.
- Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
- Baseline moderate to severe psoriasis, defined as both of the following:
- Psoriasis covering a body surface area (BSA) ≥ 10%, and;
- PGA ≥ 3, and;
- PASI ≥ 12
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- Must be in good health (except for psoriasis and psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories
- In the opinion of the investigator, must be a candidate for systemic therapy or phototherapy of psoriasis
- If a woman, before entry she must be:
- Postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or > 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL, or Surgically postmenopausal (bilateral oophorectomy), or
- Surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
- If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study and for 2 months after receiving the last administration of any study agent, or
- Not heterosexually active
- Women of childbearing potential must have a negative pregnancy test (urine and serum) prior to randomization
- Agree to avoid prolonged exposure to natural sunlight or tanning beds or phototherapy devices for the duration of the study
- Agree to avoid any prohibited concomitant medications as detailed below for the duration of the study and for 4 weeks prior to baseline unless indication otherwise
- Negative stool culture.
- Patient has the ability to provide informed consent.
Who cannot join
- Patients with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years.
- Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
- Patient with history of drug or alcohol abuse within 6 months prior to Screening.
- Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
- Patient is unable or unwilling to swallow study medication suspension.
- Patient with a significant medical condition which puts the patient at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable candidate to receive TSO or is potentially put at risk by study procedures.
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- Patients who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.
- White blood cell count ≤ 3,000/mm3 (≤ 3.0 x 109/L) or ≥ 14,000/mm3 (≥14 x 109/L)
- Platelet count ≤ 100,000/μL (≤100 x 109/L)
- Serum creatinine >2 x upper limit of normal (ULN)
- AST (SGOT) or ALT (SGPT) > 2 x ULN
- Total bilirubin >2 mg/dL (34 μmol/L)
- Hemoglobin < 9 g/dL
- Patients who are currently taking or have taken in the past 30 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- Patients who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy.
- Patients currently taking or who have taken in the past 2 weeks, topical steroids.
- Patients on a non-stable dose of vitamin D analog in the past 30 days.
- Patients currently taking or who have taken in the past 30 days any medications likely to improve psoriasis and thus interfere with evaluation. This may include, in addition to the medications listed above, phototherapy, methotrexate, hydroxyurea, or acitretin.
- Patients with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
- Patients with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody.
- Patient received non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed.
- Women who are pregnant, intending to become pregnant, breastfeeding or planning to breastfeed during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Randomized Open-label Two-arm Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis. Protocol: Psoriasis IIT
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
Psoriasis is driven by T-cell infiltration in the epidermis. The T-cells involved in psoriasis exhibit a Th17-like and a Th1-like cytokine secretion profile. This excess Th17/Th1 response is thought to play a critical role in the development of psoriasis, and reducing Th17/Th1 activity would be a potential way of halting the inflammatory process leading to psoriasis.
- Conditions
- Psoriasis
- Being tested
- TSO 2500, TSO 7500
- Keywords
- psoriasis, oral therapy, ova, Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSO 2500Drug
TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
TSO 7500Drug
Also called CNDO 201 Trichuris suis ova (TSO), Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova
12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).
| Study group | Role | What they receive |
|---|---|---|
| TSO 2500 | Active comparator | TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks Receives: Drug: TSO 2500 |
| TSO 7500 | Active comparator | TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks Receives: Drug: TSO 7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
The PASI score will be calculated within each patient at each protocol-specified time point. Changes and percent changes from pretreatment to each on-treatment time point will then be derived. Mean percent change from pre-treatment to Week 12.
Measured: up to 12 weeks
Secondary outcomes (9)
psoriasis severity
Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
Measured: week 4
psoriasis severity
Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
Measured: week 8
psoriasis severity
Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
Measured: week 12
Physicians Global Assessment (PGA)
Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
Measured: week 4
Physicians Global Assessment (PGA)
Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
Measured: week 8
Physicians Global Assessment (PGA)
Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
Measured: week 12
Change in Body surface area (BSA)
Body surface area (BSA) mean and percent change from pre-treatment
Measured: baseline and week 12
Change in Dermatology Life Quality Index (DLQI)
DLQI mean (and percent) change from pre-treatment to Week 12
Measured: baseline and at week 12
safety of TSO
The safety and tolerability of TSO will be evaluated via the frequency and severity of adverse events, changes in physical examinations, stool cultures, clinical laboratories, and vital signs.
Measured: up to week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Lebwohl
- Sponsor type
- University, hospital or other
- Collaborators
- Coronado Biosciences, Inc.
- Responsible party
- Sponsor-investigator, Mark Lebwohl, Icahn School of Medicine at Mount Sinai
- Investigators
- Mark Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836939
- Sponsor's protocol ID
- GCO 12-1881
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Barrett JC, Hansoul S, Nicolae DL, Cho JH, Duerr RH, Rioux JD, Brant SR, Silverberg MS, Taylor KD, Barmada MM, Bitton A, Dassopoulos T, Datta LW, Green T, Griffiths AM, Kistner EO, Murtha MT, Regueiro MD, Rotter JI, Schumm LP, Steinhart AH, Targan SR, Xavier RJ; NIDDK IBD Genetics Consortium; Libioulle C, Sandor C, Lathrop M, Belaiche J, Dewit O, Gut I, Heath S, Laukens D, Mni M, Rutgeerts P, Van Gossum A, Zelenika D, Franchimont D, Hugot JP, de Vos M, Vermeire S, Louis E; Belgian-French IBD Consortium; Wellcome Trust Case Control Consortium; Cardon LR, Anderson CA, Drummond H, Nimmo E, Ahmad T, Prescott NJ, Onnie CM, Fisher SA, Marchini J, Ghori J, Bumpstead S, Gwilliam R, Tremelling M, Deloukas P, Mansfield J, Jewell D, Satsangi J, Mathew CG, Parkes M, Georges M, Daly MJ. Genome-wide association defines more than 30 distinct susceptibility loci for Crohn's disease. Nat Genet. 2008 Aug;40(8):955-62. doi: 10.1038/ng.175. Epub 2008 Jun 29.
PubMed 18587394Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. doi: 10.1016/S0140-6736(07)60751-X.
PubMed 17499606Crohn BB, Ginzburg L, Oppenheimer GD. Regional ileitis: a pathologic and clinical entity. 1932. Mt Sinai J Med. 2000 May;67(3):263-8. No abstract available.
PubMed 10828911Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.
PubMed 11856078
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Two-arm Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis. Protocol: Psoriasis IIT
- ClinicalTrials.gov ID
- NCT01836939
- Acronym / sponsor ID
- GCO 12-1881
- Conditions
- Psoriasis
- Keywords
- psoriasis, oral therapy, ova, Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mark LebwohlUniversity, hospital or other
- Collaborators
- Coronado Biosciences, Inc.
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Apr 2013 (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 purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
Psoriasis is driven by T-cell infiltration in the epidermis. The T-cells involved in psoriasis exhibit a Th17-like and a Th1-like cytokine secretion profile. This excess Th17/Th1 response is thought to play a critical role in the development of psoriasis, and reducing Th17/Th1 activity would be a potential way of halting the inflammatory process leading to psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TSO 2500 | Active comparator | Drug: TSO 2500TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks |
| TSO 7500 | Active comparator | Drug: TSO 7500TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Males or females, 18 to 75 years old.
- Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
- Baseline moderate to severe psoriasis, defined as both of the following:
- Must be in good health (except for psoriasis and psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories
- In the opinion of the investigator, must be a candidate for systemic therapy or phototherapy of psoriasis
Key exclusion criteria (22 listed)
- Patients with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years.
- Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
- Patient with history of drug or alcohol abuse within 6 months prior to Screening.
- Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
- Patient is unable or unwilling to swallow study medication suspension.
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 |
|---|---|---|
| TSO 2500TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks | Drug | TSO 2500 |
| TSO 7500Also: CNDO 201 Trichuris suis ova (TSO), Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses). | Drug | TSO 7500 |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: up to 12 weeks
The PASI score will be calculated within each patient at each protocol-specified time point. Changes and percent changes from pretreatment to each on-treatment time point will then be derived. Mean percent change from pre-treatment to Week 12.
9 secondary outcomes
psoriasis severity
Time frame: week 4
psoriasis severity
Time frame: week 8
psoriasis severity
Time frame: week 12
Physicians Global Assessment (PGA)
Time frame: week 4
Physicians Global Assessment (PGA)
Time frame: week 8
Physicians Global Assessment (PGA)
Time frame: week 12
Change in Body surface area (BSA)
Time frame: baseline and week 12
Change in Dermatology Life Quality Index (DLQI)
Time frame: baseline and at week 12
safety of TSO
Time frame: up to week 38
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 14 Jan 2015.
- Background: PubMed 18587394Barrett JC, Hansoul S, Nicolae DL, Cho JH, Duerr RH, Rioux JD, Brant SR, Silverberg MS, Taylor KD, Barmada MM, Bitton A, Dassopoulos T, Datta LW, Green T, Griffiths AM, Kistner EO, Murtha MT, Regueiro MD, Rotter JI, Schumm LP, Steinhart AH, Targan SR, Xavier RJ; NIDDK IBD Genetics Consortium; Libioulle C, Sandor C, Lathrop M, Belaiche J, Dewit O, Gut I, Heath S, Laukens D, Mni M, Rutgeerts P, Van Gossum A, Zelenika D, Franchimont D, Hugot JP, de Vos M, Vermeire S, Louis E; Belgian-French IBD Consortium; Wellcome Trust Case Control Consortium; Cardon LR, Anderson CA, Drummond H, Nimmo E, Ahmad T, Prescott NJ, Onnie CM, Fisher SA, Marchini J, Ghori J, Bumpstead S, Gwilliam R, Tremelling M, Deloukas P, Mansfield J, Jewell D, Satsangi J, Mathew CG, Parkes M, Georges M, Daly MJ. Genome-wide association defines more than 30 distinct susceptibility loci for Crohn's disease. Nat Genet. 2008 Aug;40(8):955-62. doi: 10.1038/ng.175. Epub 2008 Jun 29.
- Background: PubMed 17499606Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. doi: 10.1016/S0140-6736(07)60751-X.
- Background: PubMed 10828911Crohn BB, Ginzburg L, Oppenheimer GD. Regional ileitis: a pathologic and clinical entity. 1932. Mt Sinai J Med. 2000 May;67(3):263-8. No abstract available.
- Background: PubMed 11856078Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.
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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.
Mark Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 TSO 2500 and TSO 7500 in people with Psoriasis, run by Mark Lebwohl at 1 site 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 18 inclusion and 22 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 14 Jan 2015. 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 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 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?
Psoriasis Area and Severity Index (PASI) (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 NCT01836939, which also lists 4 linked publications.
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 14 Jan 2015.