CClinicalTrials.gg
Sign In
CompletedNCT00678561Updated Dec 31, 2020Results posted

Topical CP-690,550 For Chronic Plaque Psoriasis

A Phase 2 interventional study of CP-690,550 and CP-690,550 in Psoriasis, sponsored by Pfizer. Completed at 20 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-31.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

Browse trials for

Keywords

  • chronic plaque psoriasis
  • topical treatment
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 81 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
  • Pregnant or lactating women
  • Unwilling to use appropriate contraceptive methods
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    2% CP-690,550 QD

    Drug: CP-690,550

  • Experimental
    0.2% CP-690,550 QD

    Drug: CP-690,550

  • Experimental
    0.02% CP-690,550 QD

    Drug: CP-690,550

  • Experimental
    2% CP-690,550 BID

    Drug: CP-690,550

  • Experimental
    0.2% CP-690,550 BID

    Drug: CP-690,550

  • Experimental
    0.02% CP-690,550 BID

    Drug: CP-690,550

  • Placebo comparator
    Placebo Vehicle QD

    Drug: Placebo Vehicle

  • Placebo comparator
    Placebo Vehicle BID

    Drug: Placebo Vehicle

Interventions

  • DrugCP-690,550

    Topical treatment once daily for 28 days

  • DrugCP-690,550

    Topical treatment once daily for 28 days

  • DrugCP-690,550

    Topical treatment once daily for 28 days

  • DrugCP-690,550

    Topical treatment twice daily for 28 days

  • DrugCP-690,550

    Topical treatment twice daily for 28 days

  • DrugCP-690,550

    Topical treatment twice daily for 28 days

  • DrugPlacebo Vehicle

    Topical treatment once daily for 28 days

  • DrugPlacebo Vehicle

    Topical treatment twice daily for 28 days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 4

Secondary outcomes

  1. 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".

    Time frame: Week 4

  2. 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.

    Time frame: Baseline, Week 1, 2, 3

  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.

    Time frame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)

  4. Drug Plasma Concentrations of CP-690,555

    Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.

    Time frame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28

  5. 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.

    Time frame: Day 28

07

Results

Posted Dec 31, 2020

Participant flow

During the study, enrollment into the 4 once daily dosing regimen treatment groups was discontinued in order to decrease the overall total number of participants to be enrolled.

Participant flow — Overall Study
Milestone2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Started66841717158
Completed65741516157
Not completed01102101
Withdrew: Adverse event01101000
Withdrew: Protocol violation00001100
Withdrew: Withdrawal by subject00000001

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · Percent Change
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
Percent Change2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 42.38 ± 5.83-4.76 ± 11.662.48 ± 11.50-4.17 ± 8.33-4.46 ± 9.23-1.77 ± 20.87-3.29 ± 21.34-7.14 ± 20.11
SecondaryPercentage 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".

Time frame:
Week 4
Reported as:
Number · Percentage of Participants
Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
Percentage of Participants2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Active, Clear0.00.00.00.06.70.00.00.0
Active, Almost Clear0.00.00.00.013.325.033.314.3
Vehicle, Clear0.00.00.00.00.00.00.00.0
Vehicle, Almost Clear0.00.00.00.026.725.013.30.0
SecondaryPercent 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.

Time frame:
Baseline, Week 1, 2, 3
Reported as:
Mean · percent change
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
percent change2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Week 10.00 ± 0.005.56 ± 13.61-1.39 ± 9.74-16.67 ± 33.33-1.59 ± 28.974.24 ± 16.302.13 ± 11.59-3.87 ± 7.19
Week 2-5.56 ± 8.610.93 ± 8.900.69 ± 8.630.00 ± 0.00-3.49 ± 16.240.25 ± 9.82-4.55 ± 16.11-4.42 ± 13.45
Week 30.00 ± 0.002.78 ± 6.808.73 ± 13.52-16.67 ± 28.87-4.66 ± 13.473.06 ± 22.74-2.99 ± 16.38-2.83 ± 16.00
SecondaryNumber 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.

Time frame:
Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Reported as:
Count of participants · Participants
Number of Participants With Administration Site Adverse Events
Participants2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Active00010010
Vehicle00010110
SecondaryDrug Plasma Concentrations of CP-690,555

Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.

Time frame:
0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Reported as:
Mean · nanogram per milliliter (ng/mL)
Drug Plasma Concentrations of CP-690,555
nanogram per milliliter (ng/mL)2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice Daily
0 hour post-dose0.183 ± 0.0540.116 ± 0.020NA ± NA
1 hour post-dose0.174 ± 0.046NA ± NA0.126 ± NA
2 hour post-dose0.191 ± 0.059NA ± NA0.115 ± NA
9 hour post-dose0.160 ± 0.039NA ± NA0.102 ± NA
SecondarySkin 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.

Time frame:
Day 28
Reported as:
Mean · ng/mg
Skin Biopsy Drug Concentrations
ng/mg2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
Skin Biopsy Drug Concentrations3.4145 ± 2.98772.2320 ± 2.72570.3242 ± 0.63430 ± NA8.2810 ± 10.2700.2957 ± 0.36750.0847 ± 0.12520 ± NA

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
2% CP-690,550 Once Daily—0/6 (0%)4/6 (66.7%)
0.2% CP-690,550 Once Daily—0/6 (0%)2/6 (33.3%)
0.02% CP-690,550 Once Daily—0/8 (0%)5/8 (62.5%)
Placebo Once Daily—0/4 (0%)3/4 (75%)
2% CP-690,550 Twice Daily—0/17 (0%)6/17 (35.3%)
0.2% CP-690,550 Twice Daily—0/17 (0%)11/17 (64.7%)
0.02% CP-690,550 Twice Daily—0/15 (0%)7/15 (46.7%)
Placebo Twice Daily—0/8 (0%)4/8 (50%)
Most frequent other events
Showing 10 of 38
Most frequent other events
Event2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice Daily
NasopharyngitisInfections and infestations2/61/62/80/40/171/171/151/8
HeadacheNervous system disorders2/60/60/80/40/172/170/151/8
Application site pruritusGeneral disorders0/60/60/81/40/171/170/150/8
Upper respiratory tract infectionInfections and infestations0/60/60/81/40/172/171/150/8
Musculoskeletal painMusculoskeletal and connective tissue disorders0/60/60/81/40/170/170/150/8
Skin irritationSkin and subcutaneous tissue disorders0/60/60/81/40/170/170/150/8
Atrial fibrillationCardiac disorders1/60/60/80/40/170/170/150/8
Pharyngitis streptococcalInfections and infestations0/61/60/80/40/170/170/150/8
Blood bilirubin increasedInvestigations0/61/60/80/40/170/170/150/8
Dermatitis contactSkin and subcutaneous tissue disorders1/60/61/80/40/170/170/150/8

Baseline characteristics

Age, Continuous
Age, Continuous(Years)2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice DailyTotal
Mean51.8 ± 7.345.7 ± 11.650.3 ± 17.052.5 ± 13.145.9 ± 10.543.2 ± 15.847.4 ± 13.041.1 ± 17.046.3 ± 13.5
Sex: Female, Male
Sex: Female, Male(Participants)2% CP-690,550 Once Daily0.2% CP-690,550 Once Daily0.02% CP-690,550 Once DailyPlacebo Once Daily2% CP-690,550 Twice Daily0.2% CP-690,550 Twice Daily0.02% CP-690,550 Twice DailyPlacebo Twice DailyTotal
Female1101452115
Male5583131213766
08

Study locations

20 sites
  • University of California Irvine
    Irvine, California 92697, United States
  • Therapeutics Clinical Research
    San Diego, California 92123, United States
  • RUSH University Medical Center
    Chicago, Illinois 60612, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • University of Michigan
    Ann Arbor, Michigan 48109-0314, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432-3134, United States
  • Central Dermatology, PC
    Saint Louis, Missouri 63117, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
  • The Imaging Center
    High Point, North Carolina 27262, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Oregon Medical Research Center, PC
    Portland, Oregon 97223, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • DermResearch, Inc.
    Austin, Texas 78759, United States
  • University of Utah School of Medicine
    Salt Lake City, Utah 84132, United States
  • Guildford Dermatology Specialists
    Surrey, British Columbia V3R 6A7, Canada
  • NewLab Clinical Research Inc.
    St. John's, Newfoundland and Labrador A1C 2H5, Canada
  • K.Papp Clinical Research Inc.
    Waterloo, Ontario N2J 1C4, Canada
  • Innovaderm Research, Inc.
    Montreal, Quebec H2K 4L5, Canada
  • Siena Medical Research
    Montreal, Quebec H3Z 2S6, Canada
  • Centre de Recherche Dermatologique du Quebec metropolitain
    Quebec, G1V 4X7, Canada
09

References and documents

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 ↗

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00678561
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 15, 2008
Start date
Oct 13, 2008
Primary completion
Jul 9, 2009
Completion
Jul 24, 2009
Results posted
Dec 31, 2020
Last update
Dec 31, 2020

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Psoriasis→

Other studies from this sponsor

Pfizer

Start the discussion