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Monoclonal Antibodies

PF-06700841 30 mg for Lupus

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of moderate to severe active Lupus.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 56
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have moderate to severe active Lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.
Secondary outcome measures
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.
Number of clinically significant abnormalities in clinical laboratory values.
+10 more

Side effects data

From 2022 Phase 2 trial • 194 Patients • NCT04092452
13%
Blood creatine phosphokinase increased
13%
Hidradenitis
9%
Acne
6%
Nausea
6%
Headache
2%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06826647 400mg QD
Placebo
PF-06650833 400mg QD
PF-06700841 45mg QD

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06700841 45 mgExperimental Treatment1 Intervention
PF-06700841 45 mg
Group II: PF-06700841 30 mgExperimental Treatment1 Intervention
PF-06700841 30 mg
Group III: PF-06700841 15 mgExperimental Treatment1 Intervention
PF-06700841 15 mg
Group IV: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06700841 30 mg
2019
Completed Phase 2
~350
PF-06700841 15 mg
2019
Completed Phase 2
~350
PF-06700841 45 mg
2019
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,523 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,691 Total Patients Enrolled

Media Library

PF-06700841 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03845517 — Phase 2
Lupus Research Study Groups: PF-06700841 45 mg, PF-06700841 30 mg, Placebo, PF-06700841 15 mg
Lupus Clinical Trial 2023: PF-06700841 Highlights & Side Effects. Trial Name: NCT03845517 — Phase 2
PF-06700841 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845517 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any capacity for participants to join this research?

"This clinical trial is not actively enrolling participants at this time. Initially posted on April 18th 2019 and last modified November 17th 2022, it has since been closed for new patients. For those searching for alternative studies related to lupus erythematosus, systemic there are 124 trials open presently; additionally 3 clinical trails concerning PF-06700841 30 mg are also recruiting."

Answered by AI

How many sites are administering this research endeavor?

"The trial is accepting participants from 7 different sites, located in Toronto, Bethlehem and Syracuse among other cities. It is recommended that the closest location to you be selected so as to reduce the transit burden associated with participation."

Answered by AI

Has PF-06700841 30 mg been tested for efficacy in any prior research experiments?

"Presently, there are 3 clinical trials for PF-06700841 30 mg in progress with none of those being Phase 3. Whilst the majority of testing locations are situated Sosnowiec, Idaho, a total 422 sites have been enlisted to participate."

Answered by AI

What possible side effects can be experienced with a dose of PF-06700841 30 mg?

"Based on available data, the safety rating of PF-06700841 30 mg is assessed as a 2. This drug has been tested to some degree for its security profile but there are no clinical studies that have proven its efficacy yet."

Answered by AI

For what types of individuals is this research trial appropriate?

"Prospective patients of this trial must meet the inclusion criteria, which is lupus erythematosus systemic and an age range between 18 to 75. A total of 346 individuals will be enrolled in the experiment."

Answered by AI

How many individuals is this experiment encompassing?

"Unfortunately, this clinical trial is not currently enrolling patients. It was initially posted on April 18th 2019 and most recently updated November 17th 2022. However, if you are in search of other studies, there are 124 trials looking for participants with lupus erythematosus systemic and 3 separate ones searching for volunteers to test PF-06700841 30 mg."

Answered by AI

Does this trial utilize any unique methods or approaches?

"Presently, 3 studies using PF-06700841 30 mg are in progress across 143 cities and 39 countries. The initial investigation on this pharmaceutical was conducted by Pfizer in 2018 with 246 participants completing Phase 2 clinical trials. Since then, 18336 trials have been finalized."

Answered by AI

Are participants of an advanced age eligible to join this clinical examination?

"This medical study is seeking participants who are within the age range of 18 to 75 years old."

Answered by AI
~58 spots leftby Apr 2025