NCT00678561 is a Phase 2 clinical trial of CP-690,550 in Psoriasis, sponsored by Pfizer.

Who is sponsoring NCT00678561?

NCT00678561 is sponsored by Pfizer.

What drugs are being tested in NCT00678561?

Interventions in NCT00678561: CP-690,550, CP-690,550, CP-690,550, CP-690,550, CP-690,550, CP-690,550, Placebo Vehicle, Placebo Vehicle.

Is NCT00678561 still recruiting?

NCT00678561 is currently completed. Last updated 31 December 2020.

Are results published for NCT00678561?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-12-31 · How we verify

NCT00678561

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Topical CP-690,550 For Chronic Plaque Psoriasis

Completed Phase 2 Results posted Last updated 31 December 2020

What this trial tests

Phase 2 trial testing CP-690,550 in Psoriasis in 81 participants. Completed in 24 July 2009.

Timeline

13 October 2008

Primary endpoint
9 July 2009

24 July 2009

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	81
Start date	13 October 2008
Primary completion	9 July 2009
Estimated completion	24 July 2009
Sites	20 locations across Canada, United States

Drugs / interventions tested

CP-690,550 — full drug profile →
CP-690,550 — full drug profile →
CP-690,550 — full drug profile →
CP-690,550 — full drug profile →
CP-690,550 — full drug profile →
CP-690,550 — full drug profile →
Placebo Vehicle
Placebo Vehicle

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 65, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
2% CP-690,550 Once Daily	2.38	± 5.83
0.2% CP-690,550 Once Daily	-4.76	± 11.66
0.02% CP-690,550 Once Daily	2.48	± 11.50
Placebo Once Daily	-4.17	± 8.33
2% CP-690,550 Twice Daily	-4.46	± 9.23
0.2% CP-690,550 Twice Daily	-1.77	± 20.87
0.02% CP-690,550 Twice Daily	-3.29	± 21.34
Placebo Twice Daily	-7.14	± 20.11

Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions Secondary · Week 4

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".

Active, Clear

Group	Value	95% CI
2% CP-690,550 Once Daily	0.0
0.2% CP-690,550 Once Daily	0.0
0.02% CP-690,550 Once Daily	0.0
Placebo Once Daily	0.0
2% CP-690,550 Twice Daily	6.7
0.2% CP-690,550 Twice Daily	0.0
0.02% CP-690,550 Twice Daily	0.0
Placebo Twice Daily	0.0

Active, Almost Clear

Group	Value	95% CI
2% CP-690,550 Once Daily	0.0
0.2% CP-690,550 Once Daily	0.0
0.02% CP-690,550 Once Daily	0.0
Placebo Once Daily	0.0
2% CP-690,550 Twice Daily	13.3
0.2% CP-690,550 Twice Daily	25.0
0.02% CP-690,550 Twice Daily	33.3
Placebo Twice Daily	14.3

Vehicle, Clear

Group	Value	95% CI
2% CP-690,550 Once Daily	0.0
0.2% CP-690,550 Once Daily	0.0
0.02% CP-690,550 Once Daily	0.0
Placebo Once Daily	0.0
2% CP-690,550 Twice Daily	0.0
0.2% CP-690,550 Twice Daily	0.0
0.02% CP-690,550 Twice Daily	0.0
Placebo Twice Daily	0.0

Vehicle, Almost Clear

Group	Value	95% CI
2% CP-690,550 Once Daily	0.0
0.2% CP-690,550 Once Daily	0.0
0.02% CP-690,550 Once Daily	0.0
Placebo Once Daily	0.0
2% CP-690,550 Twice Daily	26.7
0.2% CP-690,550 Twice Daily	25.0
0.02% CP-690,550 Twice Daily	13.3
Placebo Twice Daily	0.0

Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 Secondary · Baseline, Week 1, 2, 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.

Week 1

Group	Value	95% CI
2% CP-690,550 Once Daily	0.00	± 0.00
0.2% CP-690,550 Once Daily	5.56	± 13.61
0.02% CP-690,550 Once Daily	-1.39	± 9.74
Placebo Once Daily	-16.67	± 33.33
2% CP-690,550 Twice Daily	-1.59	± 28.97
0.2% CP-690,550 Twice Daily	4.24	± 16.30
0.02% CP-690,550 Twice Daily	2.13	± 11.59
Placebo Twice Daily	-3.87	± 7.19

Week 2

Group	Value	95% CI
2% CP-690,550 Once Daily	-5.56	± 8.61
0.2% CP-690,550 Once Daily	0.93	± 8.90
0.02% CP-690,550 Once Daily	0.69	± 8.63
Placebo Once Daily	0.00	± 0.00
2% CP-690,550 Twice Daily	-3.49	± 16.24
0.2% CP-690,550 Twice Daily	0.25	± 9.82
0.02% CP-690,550 Twice Daily	-4.55	± 16.11
Placebo Twice Daily	-4.42	± 13.45

Week 3

Group	Value	95% CI
2% CP-690,550 Once Daily	0.00	± 0.00
0.2% CP-690,550 Once Daily	2.78	± 6.80
0.02% CP-690,550 Once Daily	8.73	± 13.52
Placebo Once Daily	-16.67	± 28.87
2% CP-690,550 Twice Daily	-4.66	± 13.47
0.2% CP-690,550 Twice Daily	3.06	± 22.74
0.02% CP-690,550 Twice Daily	-2.99	± 16.38
Placebo Twice Daily	-2.83	± 16.00

Number of Participants With Administration Site Adverse Events Secondary · Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)

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.

Active

Group	Value	95% CI
2% CP-690,550 Once Daily	0
0.2% CP-690,550 Once Daily	0
0.02% CP-690,550 Once Daily	0
Placebo Once Daily	1
2% CP-690,550 Twice Daily	0
0.2% CP-690,550 Twice Daily	0
0.02% CP-690,550 Twice Daily	1
Placebo Twice Daily	0

Vehicle

Group	Value	95% CI
2% CP-690,550 Once Daily	0
0.2% CP-690,550 Once Daily	0
0.02% CP-690,550 Once Daily	0
Placebo Once Daily	1
2% CP-690,550 Twice Daily	0
0.2% CP-690,550 Twice Daily	1
0.02% CP-690,550 Twice Daily	1
Placebo Twice Daily	0

Drug Plasma Concentrations of CP-690,555 Secondary · 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28

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

0 hour post-dose

Group	Value	95% CI
2% CP-690,550 Twice Daily	0.183	± 0.054
0.2% CP-690,550 Twice Daily	0.116	± 0.020
0.02% CP-690,550 Twice Daily	NA	± NA

1 hour post-dose

Group	Value	95% CI
2% CP-690,550 Twice Daily	0.174	± 0.046
0.2% CP-690,550 Twice Daily	NA	± NA
0.02% CP-690,550 Twice Daily	0.126	± NA

2 hour post-dose

Group	Value	95% CI
2% CP-690,550 Twice Daily	0.191	± 0.059
0.2% CP-690,550 Twice Daily	NA	± NA
0.02% CP-690,550 Twice Daily	0.115	± NA

9 hour post-dose

Group	Value	95% CI
2% CP-690,550 Twice Daily	0.160	± 0.039
0.2% CP-690,550 Twice Daily	NA	± NA
0.02% CP-690,550 Twice Daily	0.102	± NA

Skin Biopsy Drug Concentrations Secondary · Day 28

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.

Group	Value	95% CI
2% CP-690,550 Once Daily	3.4145	± 2.9877
0.2% CP-690,550 Once Daily	2.2320	± 2.7257
0.02% CP-690,550 Once Daily	0.3242	± 0.6343
Placebo Once Daily	0	± NA
2% CP-690,550 Twice Daily	8.2810	± 10.270
0.2% CP-690,550 Twice Daily	0.2957	± 0.3675
0.02% CP-690,550 Twice Daily	0.0847	± 0.1252
Placebo Twice Daily	0	± NA

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2% CP-690,550 Once Daily

Serious: 0/6 (0%)

Deaths: —

0.2% CP-690,550 Once Daily

Serious: 0/6 (0%)

Deaths: —

0.02% CP-690,550 Once Daily

Serious: 0/8 (0%)

Deaths: —

Placebo Once Daily

Serious: 0/4 (0%)

Deaths: —

2% CP-690,550 Twice Daily

Serious: 0/17 (0%)

Deaths: —

0.2% CP-690,550 Twice Daily

Serious: 0/17 (0%)

Deaths: —

0.02% CP-690,550 Twice Daily

Serious: 0/15 (0%)

Deaths: —

Placebo Twice Daily

Serious: 0/8 (0%)

Deaths: —

Other adverse events (38 terms — click to expand)

Reaction	System	2% CP-690,550 Once Daily	0.2% CP-690,550 Once Daily	0.02% CP-690,550 Once Daily	Placebo Once Daily	2% CP-690,550 Twice Daily	0.2% CP-690,550 Twice Daily	0.02% CP-690,550 Twice Daily	Placebo Twice Daily
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Application site irritation	General disorders	—	—	—	—	—	—	—	—
Application site pruritus	General disorders	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Sunburn	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—
Blood triglycerides increased	Investigations	—	—	—	—	—	—	—	—
Cardiac murmur	Investigations	—	—	—	—	—	—	—	—
Hyperlipidaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—
Adjustment disorder with depressed mood	Psychiatric disorders	—	—	—	—	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Photosensitivity reaction	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Skin irritation	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT00678561 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases.
Schwartz DM, Bonelli M, Gadina M, O'Shea JJ. · · 2016 · cited 474× · PMID 26633291 · DOI 10.1038/nrrheum.2015.167
JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
JAK inhibitors: treatment efficacy and safety profile in patients with psoriasis.
Hsu L, Armstrong AW. · · 2014 · cited 88× · PMID 24883332 · DOI 10.1155/2014/283617
SOCS-JAK-STAT inhibitors and SOCS mimetics as treatment options for autoimmune uveitis, psoriasis, lupus, and autoimmune encephalitis.
Pandey R, Bakay M, Hakonarson H. · · 2023 · cited 45× · PMID 38022642 · DOI 10.3389/fimmu.2023.1271102
Tofacitinib.
· 2010 · cited 31× · PMID 21171673 · DOI 10.2165/11588080-000000000-00000
Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design.
Ports WC, Feldman SR, Gupta P, Tan H, et al · · 2015 · cited 16× · PMID 26267721
Repurposing approved therapeutics for new indication: Addressing unmet needs in psoriasis treatment.
Jain H, Bhat AR, Dalvi H, Godugu C, et al · · 2021 · cited 13× · PMID 34909670 · DOI 10.1016/j.crphar.2021.100041

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00678561 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 31 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00678561.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00678561

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of CP-690,550

Other recruiting trials for Psoriasis

Other Pfizer trials

Verify against primary sources