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Compensation: Varies

Number of Visits: 9

48 Participants Needed

PF-06823859 for Systemic Lupus Erythematosus

Recruiting at 39 trial locations

Overseen ByPfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Cancer, Cardiovascular event, Severe infection, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: * are adults of 18 years of age or older. * are confirmed to have CLE or SLE with involvement of the skin. * have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Adults over 18 with active CLE or SLE and skin symptoms, a CLASI-A score of at least 8, weighing between 40-130 kg can join. They must have confirmed lupus skin manifestations for at least 3 months and be willing to undergo study procedures like skin biopsies. Exclusions include recent serious cardiovascular events, severe infections, other autoimmune diseases that could affect results, certain cancers within the last five years.

Inclusion Criteria

Participant has adequate intravenous infusion access per investigator's judgement

My weight is between 40 kg and 130 kg.

I have active lupus affecting my skin for at least 3 months with a CLASI-A score of 8 or more.

See 1 more

Exclusion Criteria

I have severe lupus affecting my kidneys, needing strong medication.

I have not had a major heart or stroke event, or serious lung blood clot in the last 6 months.

I haven't had a serious infection or taken antibiotics in the last 2 months.

See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Phase 1

Participants receive the study medication or placebo every 4 weeks for 12 weeks

12 weeks

3 visits (in-person)

Treatment Phase 2

Participants continue to receive the study medication or placebo every 8 weeks for 36 weeks

36 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

Treatment Details

Interventions

PF-06823859

Trial OverviewThe trial is testing PF-06823859 against a placebo in adults with lupus affecting the skin. Participants will receive treatments via intravenous infusion. The goal is to see if PF-06823859 improves their condition compared to those who receive no drug (placebo). The study includes initial treatment, long-term extension period and follow-up totaling approximately 65 weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1Experimental Treatment1 Intervention

PF-06823859

Group II: Group 2Placebo Group1 Intervention

Placebo

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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

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