Atopic dermatitis, alopecia areata, Crohn's disease, non-segmental vitiligo, plaque psoriasis, psoriatic arthritis, systemic lupus erythematosus, and ulcerative colitis are complicated diseases; however, there may be an opportunity to target the JAK pathway in each of these conditions.2-10

TYK2/JAK1 are responsible for transducing a signal to initiate a cascade that ultimately results in upregulated genes, such as those associated with the expression of several inflammatory molecules.2

PF-06700841 is a TYK2/JAK1 inhibitor under investigation in subjects with alopecia areata, atopic dermatitis, Crohn's disease, non-segmental vitiligo, plaque psoriasis, psoriatic arthritis, systemic lupus erythematosus, or ulcerative colitis.21-28

JAK PATHWAY

JAK inhibition may be a factor in a number of inflammatory diseases, including alopecia areata, atopic dermatitis,
Crohn's disease, non-segmental vitiligo, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, and ulcerative colitis.2,6-15

Figure adapted from Paller AS et al. J Allergy Clin Immunol. 2017;140(3):633-643.

  • Chronic idiopathic inflammatory diseases of the skin and gut are characterized by a hyperactive immune milieu containing upregulated chemokines, proinflammatory cytokines, and infiltration of an assortment of innate and adaptive immune cells2,16-19
  • The Janus kinase-signal transducer and activator of transcription (JAK-STAT) is a signaling pathway by which a number of proinflammatory cytokines (eg, IL-4, IL-13) may transduce their pathophysiologic functions and contribute to immune hyperactivity2,16
  • The binding of a cytokine to its receptor leads to JAK activation, which in turn phosphorylates STATs. STATs then dimerize and translocate to the nucleus, where they may direct expression of a number of genes affecting differentiation of immune cells and lead to upregulated cytokines2,16

Now enrolling in Crohn’s Disease

For adults with moderate to severe active Crohn’s disease and an inadequate
response, loss of response, or intolerance to ≥1 prior conventional therapy21

PF-06700841 is an investigational oral TYK2/JAK1 inhibitor.1
PF-06651600 is an investigational oral JAK3/TEC inhibitor.1,30

The kinase activity of Janus kinases (JAK1, JAK3, and TYK2) and TEC family of non-receptor tyrosine kinases may play a role in the pathophysiology of several autoimmune diseases.6-11,20,31-34

This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled study to assess the efficacy and safety profile of oral PF-06700841 and PF-06651600 as induction and open-label extension treatment in subjects with moderate to severe active Crohn's disease with an inadequate response, loss of response, or intolerance to ≥1 prior conventional therapy.21

Planned countries for recruitment include: Australia, Austria, Belgium, Bosnia-Herzegovina, Canada, Croatia, Czech Republic, Georgia, Germany, Hungary, Italy, Lebanon, Poland, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, Ukraine, the United Arab Emirates, and the United States.21

VIEW STUDY DESIGN22,29

VIEW ENDPOINTS

PRIMARY ENDPOINT21

  • Proportion of subjects achieving clinically meaningful endoscopic improvement, defined as a reduction of ≥3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at week 12

KEY SELECTED SECONDARY ENDPOINTS21

  • Number of subjects with potentially clinically important findings for serious infections at week 64
  • Proportion of subjects achieving SES-CD 25 and SES-CD 50 at week 12
  • Proportion of subjects achieving endoscopic remission (defined as SES-CD ≤2) at week 12
  • Proportion of subjects achieving mucosal healing at week 12

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA21

  • 18 to 75 years of age at the time of informed consent
  • Diagnosis of Crohn’s disease for ≥3 months
  • Active endoscopic disease (SES‑CD ≥7; isolated ileal disease, SES‑CD ≥4)
  • Average daily stool frequency ≥2.5 or daily abdominal pain ≥2.0
  • Inadequate response, loss of response, or intolerance to ≥1 conventional therapy for Crohn’s disease

KEY SELECTED EXCLUSION CRITERIA21

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis, or clinical findings suggestive of ulcerative colitis
  • Presence of active (draining) fistulae, or intra-abdominal or perineal abscesses
  • Strictures with obstructive symptoms

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Now enrolling in ulcerative colitis

For adults with moderate to severe active ulcerative colitis and an inadequate
response, loss of response, or intolerance to ≥1 prior conventional therapy22

PF-06700841 is an investigational oral TYK2/JAK1 inhibitor.1
PF-06651600 is an investigational oral JAK3/TEC inhibitor.1,30

The kinase activity of Janus kinases (JAK1, JAK3, and TYK2) and TEC family of non-receptor tyrosine kinases may play a role in the pathophysiology of several autoimmune diseases.6-11,20,31-34

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of oral PF-06651600 and PF-06700841 as induction and chronic therapy in subjects with moderate to severe ulcerative colitis and an inadequate response to, loss of response to, or intolerance to ≥1 conventional therapy.22

Planned countries for recruitment include: Austria, Bulgaria, Canada, Czech Republic, Denmark, Georgia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Turkey, Ukraine, and the United States.22

VIEW STUDY DESIGN22,29

VIEW ENDPOINTS

PRIMARY ENDPOINT22

  • Change from baseline in total Mayo Score at week 8

KEY SELECTED SECONDARY ENDPOINTS22

  • Proportion of subjects achieving endoscopic remissiona at week 8
  • Proportion of subjects achieving symptomatic remissionb at week 8

aEndoscopic remission is defined as an endoscopic subscore of 0.
bSymptomatic remission is defined as a total Mayo Score of 2 points or lower, with no individual subscore >1 point, and both rectal bleeding and stool frequency subscores of 0.

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA22

  • 18 to 75 years of age at the time of informed consent
  • Diagnosis of ulcerative colitis for ≥3 months
  • Moderate to severe active ulcerative colitis
  • Inadequate response, loss of response, or intolerance to ≥1 conventional therapy for ulcerative colitis

KEY SELECTED EXCLUSION CRITERIA22

  • Women who are pregnant or breastfeeding
  • Clinical findings suggestive of Crohn's disease
  • Subjects who have a history of bowel surgery within 6 months prior to baseline

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Now enrolling in vitiligo

For adults with active non-segmental vitiligo23

PF-06700841 is an investigational oral TYK2/JAK1 inhibitor.1
PF-06651600 is an investigational oral JAK3/TEC inhibitor.1,30

The kinase activity of Janus kinases (JAK1, JAK3, and TYK2) and TEC family of non-receptor tyrosine kinases may play a role in the pathophysiology of several autoimmune diseases.6-11,20,31-34

This is a phase 2b, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study evaluating the efficacy and safety profile of PF-06651600 with a partially blinded extension period to evaluate the efficacy and safety of PF-06651600 and oral PF-06700841 in the treatment of subjects with active non-segmental vitiligo.23

Planned countries for recruitment include: Canada, Japan, and the United States.23

VIEW STUDY DESIGN23

VIEW ENDPOINTS

PRIMARY ENDPOINTS23

  • Percent change from baseline of Vitiligo Area Scoring Index (VASI) at week 24
  • Number of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) from baseline to week 56
  • Number of subjects with change from baseline in laboratory test results to week 56
  • Number of subjects reporting TEAEs and TESAEs from baseline to week 56
  • Number of specific clinical laboratory abnormalities from baseline to week 56

KEY SELECTED SECONDARY ENDPOINTS23

  • Percentage of subjects achieving ≥50% improvement in VASI from baseline (VASI50) at week 24
  • Percent change from baseline in VASI at week 20
  • Percent change from baseline in facial VASI at week 24
  • Percent change from baseline in Vitiligo Extent Score (VES) at week 24
  • Percent change from baseline in self-assessment VES (SA-VES) at week 24
  • Absolute change from baseline in VASI at week 24
  • Percentage of subjects achieving VASI50 at week 20

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA23

  • 18 to 65 years of age at the time of informed consent with moderate to severe active non-segmental vitiligo

KEY SELECTED EXCLUSION CRITERIA23

  • History of HIV or positive HIV serology at screening
  • Infected with hepatitis B or hepatitis C viruses
  • Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

For more information, visit

Now enrolling in lupus

For adults with moderate to severe, active, generalized systemic lupus erythematosus24

PF-06700841 is an investigational oral TYK2/JAK1 inhibitor.1

The kinase activity of Janus kinases (JAK1 and TYK2) may play a role in the pathophysiology of several autoimmune diseases.9-11,20

This is a phase 2b, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study evaluating the efficacy and safety profile of oral PF-06700841 in subjects with moderate to severe, active, generalized systemic lupus erythematosus who have an inadequate response to standard of care.24

Planned countries for recruitment include: United States.24

VIEW STUDY DESIGN24

VIEW ENDPOINTS

PRIMARY ENDPOINT24

  • Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at week 52

KEY SELECTED SECONDARY ENDPOINTS24

  • Time to first severe flare in PF-06700841–treated subjects relative to placebo
  • Proportion of subjects achieving the Lupus Low Disease Activity State (LLDAS) at week 52
  • Proportion of subjects achieving a reduction in prednisone (or equivalent) at week 52
  • Percentage of subjects with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) total activity score ≥10 at baseline with ≥50% reduction in CLASI-A total activity score at week 52
  • Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale at week 52

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA24

  • 18 to 75 years of age with a diagnosis of moderate to severe active lupus
  • Receiving a stable dose of or have documented failed therapy with methotrexate, azathioprine, mycophenolate/mycophenolic acid, antimalarials, or corticosteroids

KEY SELECTED EXCLUSION CRITERIA24

  • Active renal lupus or severe active central nervous system lupus
  • Cancer or history of cancer within 5 years of screening
  • History of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or pulmonary embolus
  • Active bacterial, viral, fungal, mycobacterial, or other infections
  • Psychiatric condition including recent or active suicidal ideation or behavior
  • Active fibromyalgia, myofascial, or chronic pain
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study or subjects who are unwilling or unable to use a highly effective method of contraception

For more information, visit

Now enrolling in PLAQUE PSORIASIS

For adults with mild to moderate plaque psoriasis25

PF-06700841 is an investigational topical TYK2/JAK1 inhibitor.1

The kinase activity of Janus kinases (JAK1 and TYK2) may play a role in the pathophysiology of several autoimmune diseases.9-11,20

This is a phase 2b, randomized, double-blind, vehicle-controlled, parallel-group, dose-ranging study evaluating the efficacy, safety, tolerability, and pharmacokinetics of PF-06700841 topical cream applied once or twice daily for 12 weeks in subjects with mild to moderate chronic plaque psoriasis.25

Planned countries for recruitment include: Canada and the United States.25

VIEW STUDY DESIGN5

VIEW ENDPOINTS

PRIMARY ENDPOINT25

  • Change in Psoriasis Area and Severity Index (PASI) score from baseline to week 12

KEY SELECTED SECONDARY ENDPOINTS25

  • Percentage of subjects with Physician's Global Assessment (PGA) score of clear (0) or almost clear (1) and 2 points’ improvement at weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
  • Percentage of subjects achieving PASI 75 at weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
  • Percentage change in PASI score from baseline to weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
  • Absolute Peak Pruritus Numerical Rating Scale (NRS) score at weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA25

  • 18 to 75 years of age with a diagnosis of plaque psoriasis for 6 months
  • PGA score of mild or moderate
  • BSA of 2-15%

KEY SELECTED EXCLUSION CRITERIA25

  • Other skin conditions that would interfere with the evaluation of psoriasis
  • History of herpes zoster or simplex
  • Mycobacterium tuberculosis (TB) infection

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NOW ENROLLING IN ATOPIC DERMATITIS

For adults and adolescents with mild or moderate atopic dermatitis26

PF-06700841 is an investigational topical TYK2/JAK1 inhibitor.1

The kinase activity of Janus kinases (JAK1 and TYK2) may play a role in the pathophysiology of several autoimmune diseases.6,9-11,20

This is a phase 2b, randomized, double-blind, vehicle-controlled, parallel-group, dose-ranging study to assess the efficacy, safety, tolerability and pharmacokinetics of PF-06700841 cream applied once or twice daily for 6 weeks in subjects 12 years of age and older with mild or moderate atopic dermatitis.26

Planned countries for recruitment include: Australia, Canada, and the United States.26

VIEW STUDY DESIGN5

BID=twice daily, QD=once daily.

VIEW ENDPOINTS

PRIMARY ENDPOINT26

  • Percent change from baseline in Eczema Area and Severity Index (EASI) at week 6

KEY SELECTED SECONDARY ENDPOINTS26

  • Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥2 points at week 6
  • Change from baseline in EASI total score at week 6
  • Proportion of participants achieving reduction in weekly averages of Peak Pruritus Numerical Scale (NRS) by ≥2 points
  • Percent change in affected body surface area at week 6
  • Proportion of participants achieving EASI-75 at week 6
  • Incidence of treatment-emergent adverse events at week 6

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA26

  • 12 to 75 years of age
  • Clinical diagnosis of atopic dermatitis for ≥3 months and current status of mild or moderate disease (defined by the following scores: BSA 2-20%, IGA 2-3, EASI 3-21, Peak Pruritus NRS grade ≥2)

KEY SELECTED EXCLUSION CRITERIA26

  • Other forms of dermatological diseases (other than atopic dermatitis)
  • Fitzpatrick skin type score >5
  • Clinically significant abnormal electrocardiogram, vital signs, and laboratory values
  • Infection with hepatitis B or hepatitis C viruses, herpes zoster, or Mycobacterium tuberculosis (TB)

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NOW ENROLLING IN PSORIATIC ARTHRITIS

For adults with active psoriatic arthritis27

PF-06700841 is an investigational oral TYK2/JAK1 inhibitor.1

The kinase activity of Janus kinases (JAK1 and TYK2) may play a role in the pathophysiology of several autoimmune diseases.6,9-11,20

This is a phase 2b, randomized, double-blind, placebo-controlled study of oral PF-06700841 to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.27

Planned countries for recruitment include: Australia.27

VIEW STUDY DESIGN27

QD=once daily.

VIEW ENDPOINTS

PRIMARY ENDPOINT27

  • The proportion of subjects achieving an American College of Rheumatology (ACR) 20 (ACR20) response at week 16

KEY SELECTED SECONDARY ENDPOINTS27

  • The proportion of TNF-α inhibitor–naïve subjects achieving an ACR20 response at week 16
  • The proportion of subjects achieving an ACR20 response at all treatment time points except week 16
  • The proportion of subjects achieving an ACR50 and ACR70 response at all treatment time points
  • Change from baseline in the ACR response criteria components
  • The proportion of subjects achieving a Psoriasis Area and Severity Index 75 (PASI 75), 90 (PASI 90), and 100 (PASI 100) at all treatment time points

VIEW ELIGIBILITY CRITERIA

KEY SELECTED INCLUSION CRITERIA27

  • 18 to 75 years of age with active psoriatic arthritis at screening/baseline as indicated by ≥3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening and baseline

KEY SELECTED EXCLUSION CRITERIA27

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than psoriatic arthritis
  • Current or prior history of rheumatic inflammatory disease other than psoriatic arthritis

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