PF-06700841 30 mg for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lupus Erythematosus, Systemic+1 More
PF-06700841 30 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is assessing the efficacy of PF-06700841 in treating moderate to severe active SLE in patients who have failed to respond to standard of care.

Eligible Conditions
  • Lupus Erythematosus, Systemic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Baseline through Week 56

Baseline through Week 56
Number of clinically significant abnormalities in clinical laboratory values.
Number of clinically significant abnormalities in electrocardiograms
Number of clinically significant abnormalities in vital signs
Number of discontinuations due to AE's
Number of treatment emergent adverse events (AE's)
Baseline, Week 52
Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Percentage of Participants 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
Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.
Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
Time to first severe flare in PF 06700841 treated participants relative to placebo.
Week 52
Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.
Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

PF-06651600 30 mg QD
16%Upper respiratory tract infection
10%Nasopharyngitis
8%Diarrhoea
6%Insomnia
6%Gastroenteritis
6%Bronchitis
4%Urinary tract infection
4%Dry skin
2%Pruritus
2%Folliculitis
2%Oesophageal spasm
2%Headache
2%Acne
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03715829) in the PF-06651600 30 mg QD ARM group. Side effects include: Upper respiratory tract infection with 16%, Nasopharyngitis with 10%, Diarrhoea with 8%, Insomnia with 6%, Gastroenteritis with 6%.

Trial Design

4 Treatment Groups

PF-06700841 30 mg
1 of 4
PF-06700841 15 mg
1 of 4
PF-06700841 45 mg
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

346 Total Participants · 4 Treatment Groups

Primary Treatment: PF-06700841 30 mg · Has Placebo Group · Phase 2

PF-06700841 30 mg
Drug
Experimental Group · 1 Intervention: PF-06700841 30 mg · Intervention Types: Drug
PF-06700841 15 mg
Drug
Experimental Group · 1 Intervention: PF-06700841 15 mg · Intervention Types: Drug
PF-06700841 45 mg
Drug
Experimental Group · 1 Intervention: PF-06700841 45 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through week 56

Who is running the clinical trial?

PfizerLead Sponsor
4,264 Previous Clinical Trials
7,108,116 Total Patients Enrolled
14 Trials studying Lupus Erythematosus, Systemic
57,668 Patients Enrolled for Lupus Erythematosus, Systemic
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,251 Previous Clinical Trials
4,823,596 Total Patients Enrolled
4 Trials studying Lupus Erythematosus, Systemic
315 Patients Enrolled for Lupus Erythematosus, Systemic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of Lupus.
You are male or female, between 18 and 75 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.