PsoriasisPhase 1NCT01948271
Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis
A Phase 1 study testing Trichuris Suis Ova in people with Psoriasis, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to better understand whether trichuris suis ova (TSO) ingested orally may be safe and effective in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Trichuris Suis Ova
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18-75 years old
- Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
- Baseline moderate to severe psoriasis, defined as:
- Psoriasis covering a body surface area (BSA) ≥10%;
- Physician's global assessment (PGA) ≥3, and;
- PASI ≥12
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- Must be in good health as judged by the PI, based on medical history, physical examination, and clinical laboratories
- In the opinion of the PI, must be a candidate for systemic therapy or phototherapy of psoriasis
- If a woman, before entry she must be one of the following:
- Postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or >45 years of age with amenorrhea for >6 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal (bilateral oophorectomy)
- surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy)
- 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 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
- Negative stool culture
- Subject has the ability to provide informed consent
- Subjects who are on inhaled or ophthalmic steroids are allowed
Who cannot join
- Subjects with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years
- Subject 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
- Subject with history of drug or alcohol abuse within 6 months prior to screening
- Subject with evidence of poor compliance with medical advice and instruction including diet or medication
- Subject is unable or unwilling to swallow study medication suspension
- Subject with a significant medical condition which puts the subject 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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- Subjects 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)
- Aspartate or alanine aminotransferase >2 x ULN
- Total bilirubin >2 mg/dL (34 μmol/L)
- Hemoglobin < 9 g/dL
- Subjects 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, tacrolimus, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- Subjects who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy
- Subjects currently taking or who have taken in the past 2 weeks, topical steroids
- Subjects on a non-stable dose of vitamin D analog in the past 30 days
- Subjects 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
- Subjects with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
- Subjects with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody
- Subject received non-steroidal anti-inflammatory drugs within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤350 mg/d which is allowed
- Women who are intending to become pregnant or who are breastfeeding or planning to breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis
The purpose of this research study is to better understand whether trichuris suis ova (TSO) ingested orally may be safe and effective in the treatment of psoriasis.
Read the detailed description
This is an open-label study to assess the safety and efficacy of 16 weeks of treatment with 7500 trichuris suis ova (TSO 7500) given every 2 weeks (a total of 8 doses) for the treatment of moderate-to-severe, chronic, plaque-type psoriasis.
- Conditions
- Psoriasis
- Being tested
- Trichuris Suis Ova
- Keywords
- Psoriasis, Trichuris suis ova, T-lymphocytes
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris Suis OvaDrug
Also called TSO 7500
During the treatment phase, study drug will be provided in a liquid form and will be administered every 2 weeks, starting with the Baseline visit, through Week 14.
| Study group | Role | What they receive |
|---|---|---|
| TSO 7500 | Experimental | Subjects in this arm will receive doses of 7500 trichuris suis ova every two weeks, starting at the baseline visit, for a total of 8 doses. Receives: Drug: Trichuris Suis Ova |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's area and severity index (PASI)
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI produces a numeric score that can range from 0 to 72 based on the body surface area of involvement and the severity of disease (induration, erythema and scale). A PASI-50 response is defined as ≥50% improvement in PASI score from baseline; PASI-75 and PASI-90 are similarly defined.
Measured: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16
Secondary outcomes (1)
Safety and tolerability
Evaluated via the frequency and severity of adverse events, changes in physical examinations, stool studies (ova and parasites, culture, clostridium difficile toxin, and blood), clinical laboratories (liver function tests, creatine phosphokinase, complete metabolic profile, complete blood count), and vital signs (blood pressure, pulse and temperature).
Measured: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: lack of efficacy
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice B Gottlieb, MD, PhD, Principal investigator, Tufts Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948271
- Sponsor's protocol ID
- TSOPSO13
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2013
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01948271
- Acronym / sponsor ID
- TSOPSO13
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Trichuris suis ova, T-lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Sep 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 research study is to better understand whether trichuris suis ova (TSO) ingested orally may be safe and effective in the treatment of psoriasis.
Detailed description
This is an open-label study to assess the safety and efficacy of 16 weeks of treatment with 7500 trichuris suis ova (TSO 7500) given every 2 weeks (a total of 8 doses) for the treatment of moderate-to-severe, chronic, plaque-type psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSO 7500 | Experimental | Drug: Trichuris Suis OvaSubjects in this arm will receive doses of 7500 trichuris suis ova every two weeks, starting at the baseline visit, for a total of 8 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males or females, 18-75 years old
- Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
- Baseline moderate to severe psoriasis, defined as:
- Must be in good health as judged by the PI, based on medical history, physical examination, and clinical laboratories
- In the opinion of the PI, must be a candidate for systemic therapy or phototherapy of psoriasis
Key exclusion criteria (22 listed)
- Subjects with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years
- Subject 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
- Subject with history of drug or alcohol abuse within 6 months prior to screening
- Subject with evidence of poor compliance with medical advice and instruction including diet or medication
- Subject 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 |
|---|---|---|
| Trichuris Suis OvaAlso: TSO 7500During the treatment phase, study drug will be provided in a liquid form and will be administered every 2 weeks, starting with the Baseline visit, through Week 14. | Drug | TSO 7500 |
Primary outcome
Physician's area and severity index (PASI)
Time frame: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI produces a numeric score that can range from 0 to 72 based on the body surface area of involvement and the severity of disease (induration, erythema and scale). A PASI-50 response is defined as ≥50% improvement in PASI score from baseline; PASI-75 and PASI-90 are similarly defined.
1 secondary outcome
Safety and tolerability
Time frame: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38
Results and safety
The study was stopped early (reason given: lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- 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.
- Individual participant dataSharing planned: No
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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.
Alice B Gottlieb, MD, PhD principal investigator
Tufts Medical Center, Department of Dermatology
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 Trichuris Suis Ova in people with Psoriasis, run by Tufts Medical Center 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 19 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: stopped early, as of the sponsor's last update on 15 Sep 2016. 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 was stopped early (reason given: lack of efficacy). 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?
Physician's area and severity index (PASI) (time frame: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16). 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 NCT01948271, 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 15 Sep 2016.