PsoriasisPhase 2NCT01006096
Erlotinib for Treatment of Psoriasis
A Phase 2 study testing erlotinib in people with Psoriasis, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of moderate to severe psoriasis
- Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
- Must be able to swallow tablets
- Must be able to provide written informed consent
- Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.
Who cannot join
- Use of concurrent agents/therapies for psoriasis
- Bilirubin > 3 X ≥ ULN or moderate to severe hepatic impairment
- Pregnant or breast-feeding females
- Subjects currently receiving other anticancer treatments
- Subjects currently receiving other biologic treatments
- Subjects currently receiving blood thinners (warfarin or heparin)
- Subjects who currently smoke
- Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.
Read the detailed description
Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinibDrug
Also called Tarceva
100mg tablet, once daily for 16 weeks
placebo tabletOther
placebo tablet (lactose), once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Not described Receives: Drug: erlotinib |
| Placebo tablets | Placebo comparator | Not described Receives: Other: placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA).
Measured: week 4, 8, 12, 16, and 24
Secondary outcomes (2)
To determine the rate of dose reduction or interruption as a result of adverse events.
Measured: week 4, 8, 12, 16, and 24
To determine quality of life using the Dermatology Life Quality Index (DLQI).
Measured: week 4, 8, 12, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
Why it stopped: IND not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Investigators
- Anne E Laumann, MBChB, MRCP (UK), Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006096
- Sponsor's protocol ID
- MEL-041509
- Status last verified
- Nov 2014
- First submitted
- 29 Oct 2009
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
PubMed 17314973Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
PubMed 16014882Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.
PubMed 16990857Wierzbicka E, Tourani JM, Guillet G. Improvement of psoriasis and cutaneous side-effects during tyrosine kinase inhibitor therapy for renal metastatic adenocarcinoma. A role for epidermal growth factor receptor (EGFR) inhibitors in psoriasis? Br J Dermatol. 2006 Jul;155(1):213-4. doi: 10.1111/j.1365-2133.2006.07299.x. No abstract available.
PubMed 16792781Ben-Bassat H, Vardi DV, Gazit A, Klaus SN, Chaouat M, Hartzstark Z, Levitzki A. Tyrphostins suppress the growth of psoriatic keratinocytes. Exp Dermatol. 1995 Apr;4(2):82-8. doi: 10.1111/j.1600-0625.1995.tb00227.x.
PubMed 7640880Powell TJ, Ben-Bassat H, Klein BY, Chen H, Shenoy N, McCollough J, Narog B, Gazit A, Harzstark Z, Chaouat M, Levitzki R, Tang C, McMahon J, Shawver L, Levitzki A. Growth inhibition of psoriatic keratinocytes by quinazoline tyrosine kinase inhibitors. Br J Dermatol. 1999 Nov;141(5):802-10. doi: 10.1046/j.1365-2133.1999.03152.x.
PubMed 10583160Ben-Bassat H, Klein BY. Inhibitors of tyrosine kinases in the treatment of psoriasis. Curr Pharm Des. 2000 Jun;6(9):933-42. doi: 10.2174/1381612003400182.
PubMed 10828317Ben-Bassat H, Levitzki A. Inhibitors of tyrosine kinases in the treatment of psoriasis. Isr Med Assoc J. 2000 Jul;2 Suppl:69-73. No abstract available.
PubMed 10909421Halin C, Fahrngruber H, Meingassner JG, Bold G, Littlewood-Evans A, Stuetz A, Detmar M. Inhibition of chronic and acute skin inflammation by treatment with a vascular endothelial growth factor receptor tyrosine kinase inhibitor. Am J Pathol. 2008 Jul;173(1):265-77. doi: 10.2353/ajpath.2008.071074. Epub 2008 Jun 5.
PubMed 18535184Forsberg S, Ostman A, Rollman O. Regeneration of human epidermis on acellular dermis is impeded by small-molecule inhibitors of EGF receptor tyrosine kinase. Arch Dermatol Res. 2008 Oct;300(9):505-16. doi: 10.1007/s00403-008-0853-2. Epub 2008 Apr 30.
PubMed 18446355Neyns B, Meert V, Vandenbroucke F. Cetuximab treatment in a patient with metastatic colorectal cancer and psoriasis. Curr Oncol. 2008 Aug;15(4):196-7. doi: 10.3747/co.v15i4.228.
PubMed 18769609Trivin F, Boucher E, Raoul JL. Complete sustained regression of extensive psoriasis with cetuximab combination chemotherapy. Acta Oncol. 2004;43(6):592-3. doi: 10.1080/02841860410020211. No abstract available.
PubMed 15370619
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01006096
- Acronym / sponsor ID
- MEL-041509
- Conditions
- Psoriasis
- Keywords
- Psoriasis, double-blind, randomized, placebo-controlled, erlotinib, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- OSI Pharmaceuticals
- First posted
- 2 Nov 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 purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.
Detailed description
Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.
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 |
|---|---|---|
| Erlotinib | Experimental | Drug: erlotinib |
| Placebo tablets | Placebo comparator | Other: placebo tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of moderate to severe psoriasis
- Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
- Must be able to swallow tablets
- Must be able to provide written informed consent
- Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.
Key exclusion criteria (8 listed)
- Use of concurrent agents/therapies for psoriasis
- Bilirubin > 3 X ≥ ULN or moderate to severe hepatic impairment
- Pregnant or breast-feeding females
- Subjects currently receiving other anticancer treatments
- Subjects currently receiving other biologic treatments
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 |
|---|---|---|
| erlotinibAlso: Tarceva100mg tablet, once daily for 16 weeks | Drug | Erlotinib |
| placebo tabletplacebo tablet (lactose), once daily for 16 weeks | Other | Placebo tablets |
Primary outcome
To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA).
Time frame: week 4, 8, 12, 16, and 24
2 secondary outcomes
To determine the rate of dose reduction or interruption as a result of adverse events.
Time frame: week 4, 8, 12, 16, and 24
To determine quality of life using the Dermatology Life Quality Index (DLQI).
Time frame: week 4, 8, 12, 16, and 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
- Background: PubMed 17314973Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
- Background: PubMed 16014882Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
- Background: PubMed 16990857Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.
- Background: PubMed 16792781Wierzbicka E, Tourani JM, Guillet G. Improvement of psoriasis and cutaneous side-effects during tyrosine kinase inhibitor therapy for renal metastatic adenocarcinoma. A role for epidermal growth factor receptor (EGFR) inhibitors in psoriasis? Br J Dermatol. 2006 Jul;155(1):213-4. doi: 10.1111/j.1365-2133.2006.07299.x. No abstract available.
- Background: PubMed 7640880Ben-Bassat H, Vardi DV, Gazit A, Klaus SN, Chaouat M, Hartzstark Z, Levitzki A. Tyrphostins suppress the growth of psoriatic keratinocytes. Exp Dermatol. 1995 Apr;4(2):82-8. doi: 10.1111/j.1600-0625.1995.tb00227.x.
- Background: PubMed 10583160Powell TJ, Ben-Bassat H, Klein BY, Chen H, Shenoy N, McCollough J, Narog B, Gazit A, Harzstark Z, Chaouat M, Levitzki R, Tang C, McMahon J, Shawver L, Levitzki A. Growth inhibition of psoriatic keratinocytes by quinazoline tyrosine kinase inhibitors. Br J Dermatol. 1999 Nov;141(5):802-10. doi: 10.1046/j.1365-2133.1999.03152.x.
- Background: PubMed 10828317Ben-Bassat H, Klein BY. Inhibitors of tyrosine kinases in the treatment of psoriasis. Curr Pharm Des. 2000 Jun;6(9):933-42. doi: 10.2174/1381612003400182.
- Background: PubMed 10909421Ben-Bassat H, Levitzki A. Inhibitors of tyrosine kinases in the treatment of psoriasis. Isr Med Assoc J. 2000 Jul;2 Suppl:69-73. No abstract available.
- Background: PubMed 18535184Halin C, Fahrngruber H, Meingassner JG, Bold G, Littlewood-Evans A, Stuetz A, Detmar M. Inhibition of chronic and acute skin inflammation by treatment with a vascular endothelial growth factor receptor tyrosine kinase inhibitor. Am J Pathol. 2008 Jul;173(1):265-77. doi: 10.2353/ajpath.2008.071074. Epub 2008 Jun 5.
- Background: PubMed 18446355Forsberg S, Ostman A, Rollman O. Regeneration of human epidermis on acellular dermis is impeded by small-molecule inhibitors of EGF receptor tyrosine kinase. Arch Dermatol Res. 2008 Oct;300(9):505-16. doi: 10.1007/s00403-008-0853-2. Epub 2008 Apr 30.
- Background: PubMed 18769609Neyns B, Meert V, Vandenbroucke F. Cetuximab treatment in a patient with metastatic colorectal cancer and psoriasis. Curr Oncol. 2008 Aug;15(4):196-7. doi: 10.3747/co.v15i4.228.
- Background: PubMed 15370619Trivin F, Boucher E, Raoul JL. Complete sustained regression of extensive psoriasis with cetuximab combination chemotherapy. Acta Oncol. 2004;43(6):592-3. doi: 10.1080/02841860410020211. 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.
Anne E Laumann, MBChB, MRCP (UK) principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib in people with Psoriasis, run by Northwestern University 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Nov 2014. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA). (time frame: week 4, 8, 12, 16, and 24). 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 NCT01006096, which also lists 12 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 10 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.