PF-07275315 + PF-07264660 for Eczema

Recruiting at 113 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must not be taking: Systemic immunosuppressants, Antimicrobials

Disqualifiers: SLE, Type 1 diabetes, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatments, PF-07275315 (an anti-IL4/13/TSLP therapy) and PF-07264660, to determine their safety and effectiveness for people with atopic dermatitis (AD), a chronic itchy and red skin rash. It aims to assist those who haven't found relief with creams or ointments. The trial includes different stages where participants may receive one of the study medicines or a placebo (a look-alike without active medicine). People with moderate to severe AD for at least six months who haven't responded well to topical treatments might be suitable candidates. Participants will receive several injections over a period of up to 52 weeks. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering a chance to contribute to potential new therapies for AD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that you cannot use certain prohibited medications during the study. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PF-07275315 and PF-07264660 are under investigation for their safety in treating atopic dermatitis (AD), a type of eczema that causes itchy, red skin. Specific information about side effects is not yet available, but their presence in advanced trials indicates some safety in earlier stages.

In earlier studies, treatments like these are typically tested in small groups first to assess safety before progressing to larger trials. This suggests that previous patients likely did not experience serious side effects, or the treatments would not have advanced.

However, as with any clinical trial, there is always a risk of side effects. Researchers will closely monitor participants in the current study to ensure their safety. Prospective participants should discuss any concerns with the research team and understand the potential risks and benefits before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07275315 and PF-07264660 for eczema because they represent a new approach compared to standard treatments like topical corticosteroids and calcineurin inhibitors. PF-07275315 and PF-07264660 are both investigational drugs that target specific pathways in the immune system, potentially reducing inflammation with more precision. Unlike traditional treatments that often have broad effects and side effects, these drugs aim to be more selective, which could lead to fewer side effects and better management of eczema symptoms. This targeted approach is a promising development in offering patients more effective and safer options.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that targeting IL-13, a key factor in inflammation, can effectively treat atopic dermatitis, a type of eczema. This trial tests PF-07275315 for its ability to target this process and reduce symptoms. Early results suggest this method could be promising for people with moderate to severe eczema. Meanwhile, PF-07264660 is another treatment option in this trial, tested for safety and effectiveness, though limited information exists on its efficacy for eczema. Both treatments are compared to a placebo to assess their true impact on eczema. ^{1 3 4 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults over 18 with moderate to severe atopic dermatitis (AD), diagnosed at least 6 months ago, who haven't responded well to topical treatments or for whom these are not suitable. Participants must have a BMI of 17.5-40 and weigh over 45 kg. Exclusions include significant allergies or autoimmune diseases, recent serious infections, other skin conditions that could affect AD assessment, psychiatric risks, prohibited medication use, recent phototherapy or investigational drug use.

Inclusion Criteria

My BMI is between 17.5 and 40, and I weigh more than 100 lbs.

I have had chronic atopic dermatitis for over 6 months, with treatments not working well.

Exclusion Criteria

Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; Irritable bowel syndrome; Multiple Sclerosis

History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, except to single, identified, avoidable allergens (eg, peanut allergy)

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07275315, PF-07264660, or placebo as multiple injections over 12 weeks

12 weeks

Stage 1: 8 visits, Stage 2: 4 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07264660
• PF-07275315
• Placebo

Trial Overview The trial is testing two potential medications for AD: PF-07275315 and PF-07264660 against a placebo. These are administered as injections in the clinic across different schedules in Stage 1 and Stage 2 of the study. The trial aims to determine their safety and effectiveness by comparing outcomes between those receiving the drugs and those on placebo over up to an approximately 20-month period.

How Is the Trial Designed?

Group I: Stage 4_Placebo Experimental Treatment 1 Intervention

Stage 2 Placebo Injections for 12 weeks

Group II: Stage 4_PF-07264660_Dose C Experimental Treatment 1 Intervention

Stage 4 PF-07264660 Injections for 12 weeks

Group III: Stage 4_PF-07264660_Dose B Experimental Treatment 1 Intervention

Stage 4 PF-07264660 Injections for 12 weeks

Group IV: Stage 4_PF-07264660_Dose A Experimental Treatment 1 Intervention

Stage 4 PF-07264660 Injections for 12 weeks

Group V: Stage 3_Placebo+PF-07275315_Dose A Experimental Treatment 2 Interventions

Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.

Group VI: Stage 3_PF-07275315_Dose B Experimental Treatment 1 Intervention

Stage 3 PF-07275315 Injections for 32 weeks.

Group VII: Stage 2_Placebo Experimental Treatment 1 Intervention

Stage 2 Placebo Injections over 12 weeks.

Group VIII: Stage 2_PF-07275315 _Dose D Experimental Treatment 2 Interventions

Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.

Group IX: Stage 2_PF-07275315 _Dose C Experimental Treatment 1 Intervention

Stage 2 PF-07275315 Injections over 12 weeks.

Group X: Stage 2_PF-07275315 _Dose B Experimental Treatment 1 Intervention

Stage 2 PF-07275315 Injections over 12 weeks.

Group XI: Stage 2_PF-07275315 _Dose A Experimental Treatment 1 Intervention

Stage 2 PF-07275315 Injections over 12 weeks.

Group XII: Stage 1_Placebo Experimental Treatment 1 Intervention

Stage 1 Placebo Injections over 12 weeks

Group XIII: Stage 1_PF-07275315 Experimental Treatment 1 Intervention

Stage 1 PF-07275315 Injections over 12 weeks

Group XIV: Stage 1_PF-07264660 Experimental Treatment 1 Intervention

Stage 1 PF-07264660 Injections over 12 weeks

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Dupilumab, which blocks the IL-4 receptor, has been shown to have a protective role against the IL-23-IL-17 signaling pathway in entheseal tissues, suggesting that IL-4 and IL-13 may help regulate inflammation in conditions like psoriatic arthritis (PsA).

The study found that IL-4 and IL-13 can reduce the production of IL-23 in response to inflammatory stimuli, and their presence in synovial fluid from PsA patients indicates their involvement in disease processes, which may explain the emergence of musculoskeletal issues during dupilumab therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of entheseal IL-23 expression by IL-4 and IL-13 as an explanation for arthropathy development under dupilumab therapy. Bridgewood, C., Sharif, K., Freeston, J., et al.[2021]

In a systematic review and meta-analysis of 25 clinical trials involving adult atopic dermatitis (AD), the placebo response rates at 12 weeks were found to be 39.9% for EASI50, 20.9% for EASI75, and 9.0% for EASI90, indicating a notable response even without active treatment.

The study revealed that the placebo response in AD patients was significantly higher than that observed in psoriasis patients, highlighting the unique and fluctuating nature of AD and the importance of consistent topical treatment to manage disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in phase 2 and 3 trials of systemic and biological therapies for atopic dermatitis-a systematic review and meta-analysis. Andreasen, TH., Christensen, MO., Halling, AS., et al.[2021]

In a phase 2 study involving 209 adults with moderate-to-severe atopic dermatitis, lebrikizumab 125 mg administered every 4 weeks significantly improved skin condition, with 82.4% of patients achieving at least a 50% reduction in eczema severity compared to 62.3% in the placebo group.

The safety profile of lebrikizumab was comparable to placebo, with most adverse events being mild or moderate, indicating that it can be safely used as an add-on therapy to topical corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). Simpson, EL., Flohr, C., Eichenfield, LF., et al.[2022]

A study involving 1089 participants (631 with atopic dermatitis and 458 controls) identified specific single-nucleotide polymorphisms (SNPs) in the IL-13 and IL-13Rα1 genes that are associated with an increased risk of developing atopic dermatitis, particularly the allergic type (ADe).

The haplotype TCGG in the IL-13Rα1 gene was significantly linked to ADe, suggesting that gene interactions, particularly between IL-13 and IL-13Rα1, play a crucial role in the pathogenesis of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of polymorphisms in genes encoding IL-4, IL-13 and their receptors with atopic dermatitis in a Korean population. Namkung, JH., Lee, JE., Kim, E., et al.[2022]

Mice lacking the TWEAK receptor (Fn14) in keratinocytes showed resistance to severe atopic dermatitis (AD) symptoms, indicating that TWEAK plays a significant role in the disease's development.

Blocking TWEAK in wild-type mice with AD resulted in a reduction of skin inflammation and other pathological features, demonstrating that targeting TWEAK could be as effective as targeting IL-13 for treating AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TNF-like weak inducer of apoptosis inhibition is comparable to IL-13 blockade in ameliorating atopic dermatitis inflammation. Gupta, RK., Miller, J., Croft, M.[2023]

Tacrolimus, originally used to prevent organ rejection in transplants, has been successfully developed into an ointment for treating atopic dermatitis, demonstrating its versatility as an immunomodulator.

The approval of 0.03% and 0.1% tacrolimus ointment (Protopic) as a first-in-class treatment was supported by extensive nonclinical pharmacology and toxicology studies, ensuring its safety and efficacy for patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus pharmacology and nonclinical studies: from FK506 to protopic. Bekersky, I., Lilja, H., Lawrence, I.[2021]

Tacrolimus hydrate (FK506) ointment effectively suppressed both the development and severity of spontaneous dermatitis in NC/Nga mice, demonstrating its therapeutic potential against established dermatitis.

FK506 ointment reduced inflammatory markers such as CD4-positive T cells, mast cells, eosinophils, and plasma IgE levels, suggesting it works by inhibiting inflammatory cell activation and blocking cytokine activity, making it a promising alternative to traditional steroid treatments that may have side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tacrolimus hydrate (FK506) ointment on spontaneous dermatitis in NC/Nga mice. Hiroi, J., Sengoku, T., Morita, K., et al.[2019]

In a phase IIa trial involving 64 adults with moderate-to-severe atopic dermatitis, dupilumab significantly improved health-related quality of life (HRQoL) as measured by the Quality of Life Index of Atopic Dermatitis (QoLIAD) after 12 weeks compared to placebo, with a mean percentage change of -64.0% versus -11.1%.

Improvements in QoLIAD scores were strongly correlated with clinical efficacy outcomes, such as the Eczema Area and Severity Index (EASI) and various pruritus scales, indicating that dupilumab not only enhances quality of life but also effectively reduces the severity of atopic dermatitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Tsianakas, A., Luger, TA., Radin, A.[2019]

FK506 ointment effectively suppresses dermatitis in a mouse model of atopic dermatitis by reducing local inflammatory markers like IL-4 and IFN-gamma, indicating its therapeutic potential.

The treatment works locally without causing systemic immune suppression, which is important for maintaining overall immune function while managing skin inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical application of FK506 (tacrolimus) ointment inhibits mite antigen-induced dermatitis by local action in NC/Nga mice. Sasakawa, T., Higashi, Y., Sakuma, S., et al.[2017]

Tacrolimus (FK506) is a new immunomodulator that effectively treats skin conditions like atopic dermatitis by inhibiting T cell activity, with minimal systemic absorption and limited side effects.

In clinical trials, topical tacrolimus ointment (0.03-0.3%) has been shown to significantly reduce symptoms of atopic dermatitis in both adults and children, with local irritation being the most common side effect, which is usually temporary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus: a review of its use for the management of dermatoses. Gupta, AK., Adamiak, A., Chow, M.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05995964

NCT05995964 | A Study To Learn About Two ... The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ...

2. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct05995964-atopic-dermatitis-trial

Clinical Trial for Atopic Dermatitis. The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-pf-07275315-and-pf-07264660-for-adults-with-moderate-to-severe-atopic-dermatitis/

Study on the Effects of PF-07275315 and PF-07264660 for ... The purpose of the study is to evaluate how effective and safe these treatments are compared to a placebo in adults with moderate to severe ...

4. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-7-2023-c757d

PF-07275315 + PF-07264660 for Eczema The trial aims to determine their safety and effectiveness by comparing outcomes between those receiving the drugs and those on placebo over up to an ...

5. synapse.patsnap.com synapse.patsnap.com/drug/e772c8fe6c854ca6a24570280bab967d

PF-07264660 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Third-Party Open, Placebo-Controlled, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, ...

6. mountsinai.org mountsinai.org/clinical-trials/study-to-learn-about-two-study-medicines-pf-07275315-pf-07264660-in-people-who-have-moderate-to-severe-atopic-dermatitis

A Study To Learn About Two Study Medicines (PF ... The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ( ...

7. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT05995964

NCT05995964 The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD) ...