PsoriasisPhase 2NCT00678561

Topical CP-690,550 For Chronic Plaque Psoriasis

A Phase 2 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Psoriasis
What is being tested?: CP-690,550
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 20 sitesin 2 countries
Study dates: 13 Oct 2008to 24 Jul 2009
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Having chronic plaque psoriasis for at least 6 months
Able to withdraw all prior psoriasis treatments
Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Who cannot join

Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
Pregnant or lactating women
Unwilling to use appropriate contraceptive methods

Trial locations and contacts

20 sites in 2 countries.

Country

City, postcode or hospital

20 sites in 2 countries

United States14 sites

University of Michigan
Ann Arbor, Michigan, 48109-0314
DermResearch, Inc.
Austin, Texas, 78759
Tufts Medical Center
Boston, Massachusetts, 02111
RUSH University Medical Center
Chicago, Illinois, 60612
Minnesota Clinical Study Center
Fridley, Minnesota, 55432-3134
Dermatology Consulting Services
High Point, North Carolina, 27262
The Imaging Center
High Point, North Carolina, 27262
University of California Irvine
Irvine, California, 92697
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Oregon Health & Science University
Portland, Oregon, 97239
University of Utah School of Medicine
Salt Lake City, Utah, 84132
Therapeutics Clinical Research
San Diego, California, 92123
Central Dermatology, PC
St Louis, Missouri, 63117
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

Innovaderm Research, Inc.
Montreal, Quebec, H2K 4L5
Siena Medical Research
Montreal, Quebec, H3Z 2S6
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C 2H5
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

Official title: PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

Conditions: Psoriasis
Being tested: CP-690,550, Placebo Vehicle
Keywords: chronic plaque psoriasis, topical treatment
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-690,550Drug
Topical treatment once daily for 28 days
CP-690,550Drug
Topical treatment once daily for 28 days
CP-690,550Drug
Topical treatment once daily for 28 days
CP-690,550Drug
Topical treatment twice daily for 28 days
CP-690,550Drug
Topical treatment twice daily for 28 days
CP-690,550Drug
Topical treatment twice daily for 28 days
Placebo VehicleDrug
Topical treatment once daily for 28 days
Placebo VehicleDrug
Topical treatment twice daily for 28 days

Study groups in NCT00678561
Study group	Role	What they receive
2% CP-690,550 QD	Experimental	Not described Receives: Drug: CP-690,550
0.2% CP-690,550 QD	Experimental	Not described Receives: Drug: CP-690,550
0.02% CP-690,550 QD	Experimental	Not described Receives: Drug: CP-690,550
2% CP-690,550 BID	Experimental	Not described Receives: Drug: CP-690,550
0.2% CP-690,550 BID	Experimental	Not described Receives: Drug: CP-690,550
0.02% CP-690,550 BID	Experimental	Not described Receives: Drug: CP-690,550
Placebo Vehicle QD	Placebo comparator	Not described Receives: Drug: Placebo Vehicle
Placebo Vehicle BID	Placebo comparator	Not described Receives: Drug: Placebo Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Measured: Baseline, Week 4

Secondary outcomes (5)

Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".
Measured: Week 4
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Measured: Baseline, Week 1, 2, 3
Number of Participants With Administration Site Adverse Events
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.
Measured: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Drug Plasma Concentrations of CP-690,555
Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Measured: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Skin Biopsy Drug Concentrations
Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 200824 Jul 2009

First posted15 May 2008 (estimated)
Study start13 Oct 2008
Primary completion9 Jul 2009
Study completion24 Jul 2009

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.
More trials run by PfizerThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00678561
Sponsor's protocol ID: A3921038
Status last verified: Dec 2020
First submitted: 13 May 2008
Last updated: 31 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.
PubMed 26267721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS
ClinicalTrials.gov ID: NCT00678561
Acronym / sponsor ID: A3921038
Conditions: Psoriasis
Keywords: chronic plaque psoriasis, topical treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 Oct 2008 (actual)
Primary completion: 9 Jul 2009 (actual)
Study completion: 24 Jul 2009 (actual)
First posted: 15 May 2008 (estimated)
Results: Posted 31 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
2% CP-690,550 QD	Experimental	Drug: CP-690,550
0.2% CP-690,550 QD	Experimental	Drug: CP-690,550
0.02% CP-690,550 QD	Experimental	Drug: CP-690,550
2% CP-690,550 BID	Experimental	Drug: CP-690,550
0.2% CP-690,550 BID	Experimental	Drug: CP-690,550
0.02% CP-690,550 BID	Experimental	Drug: CP-690,550
Placebo Vehicle QD	Placebo comparator	Drug: Placebo Vehicle
Placebo Vehicle BID	Placebo comparator	Drug: Placebo Vehicle

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Having chronic plaque psoriasis for at least 6 months
Able to withdraw all prior psoriasis treatments
Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Key exclusion criteria (3 listed)

Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
Pregnant or lactating women
Unwilling to use appropriate contraceptive methods

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
CP-690,550Topical treatment once daily for 28 days	Drug	2% CP-690,550 QD
CP-690,550Topical treatment once daily for 28 days	Drug	0.2% CP-690,550 QD
CP-690,550Topical treatment once daily for 28 days	Drug	0.02% CP-690,550 QD
CP-690,550Topical treatment twice daily for 28 days	Drug	2% CP-690,550 BID
CP-690,550Topical treatment twice daily for 28 days	Drug	0.2% CP-690,550 BID
CP-690,550Topical treatment twice daily for 28 days	Drug	0.02% CP-690,550 BID
Placebo VehicleTopical treatment once daily for 28 days	Drug	Placebo Vehicle QD
Placebo VehicleTopical treatment twice daily for 28 days	Drug	Placebo Vehicle BID

Primary outcome

Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
Time frame: Baseline, Week 4
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.

5 secondary outcomes

Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
Time frame: Week 4
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
Time frame: Baseline, Week 1, 2, 3
Number of Participants With Administration Site Adverse Events
Time frame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Drug Plasma Concentrations of CP-690,555
Time frame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Skin Biopsy Drug Concentrations
Time frame: Day 28

Results and safety

Results posted to the registry on 31 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% CP-690,550 Once Daily	6	6
0.2% CP-690,550 Once Daily	6	5
0.02% CP-690,550 Once Daily	8	7
Placebo Once Daily	4	4
2% CP-690,550 Twice Daily	17	15
0.2% CP-690,550 Twice Daily	17	16
0.02% CP-690,550 Twice Daily	15	15
Placebo Twice Daily	8	7

Primary outcome: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: Percent Change

Measure	2% CP-690,550 Once Daily n = 6	0.2% CP-690,550 Once Daily n = 6	0.02% CP-690,550 Once Daily n = 8	Placebo Once Daily n = 4	2% CP-690,550 Twice Daily n = 15	0.2% CP-690,550 Twice Daily n = 16	0.02% CP-690,550 Twice Daily n = 15	Placebo Twice Daily n = 7
Value	2.38 (5.83)	-4.76 (11.66)	2.48 (11.50)	-4.17 (8.33)	-4.46 (9.23)	-1.77 (20.87)	-3.29 (21.34)	-7.14 (20.11)

Population analysed: Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy parameter. N (number of participants analyzed) is signifying those participants who were evaluable for this measure.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% CP-690,550 Once Daily	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
0.2% CP-690,550 Once Daily	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
0.02% CP-690,550 Once Daily	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Placebo Once Daily	0 of 4 (0%)	3 of 4 (75%)	Not reported
2% CP-690,550 Twice Daily	0 of 17 (0%)	6 of 17 (35.3%)	Not reported
0.2% CP-690,550 Twice Daily	0 of 17 (0%)	11 of 17 (64.7%)	Not reported
0.02% CP-690,550 Twice Daily	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
Placebo Twice Daily	0 of 8 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26267721Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
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RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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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.

Pfizer CT.gov Call Center study director

Pfizer

20 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 20 sites in 2 countries.

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 3 inclusion and 3 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. 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 31 Dec 2020). 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?

Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (time frame: Baseline, Week 4). 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 NCT00678561, 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 31 Dec 2020.