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CLINICAL TRIALS PROFILE FOR OLUMIANT

All Clinical Trials for Olumiant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03921554 ↗	JAK Inhibitor Treatment in AGS	Active, not recruiting	Eli Lilly and Company	Phase 2	2019-06-03	The primary objective of this study is to assess safety as well as efficacy of baricitinib, a Janus Kinase (JAK) inhibitor, in patients with Aicardi Goutières Syndrome (AGS), a multisystem heritable disorder of the innate immunity resulting in excessive interferon production
NCT03921554 ↗	JAK Inhibitor Treatment in AGS	Active, not recruiting	Adeline Vanderver, MD	Phase 2	2019-06-03	The primary objective of this study is to assess safety as well as efficacy of baricitinib, a Janus Kinase (JAK) inhibitor, in patients with Aicardi Goutières Syndrome (AGS), a multisystem heritable disorder of the innate immunity resulting in excessive interferon production
NCT04131738 ↗	Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation	Recruiting	Washington University School of Medicine	Phase 1	2020-04-07	In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data suggest that inhibition of IFNy and IL-6, directly and using downstream JAK Inhibitors, may be an effective strategy to decrease toxicities and improve disease control for patients undergoing Allogeneic HSCT. Baricitinib, as a JAK1/2 inhibitor, has shown superiority to other JAK inhibitors in preclinical GVHD models. The purpose of this phase I clinical trial is to determine the safety of baricitinib with HSCT measured by the effect on engraftment and grade III-IV acute graft-versus-host-disease (aGVHD).
NCT04345289 ↗	Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia	Not yet recruiting	Thomas Benfield	Phase 3	2020-04-20	CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
NCT04390464 ↗	mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R)	Recruiting	Cambridge University Hospitals NHS Foundation Trust	Phase 4	2020-05-08	TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential treatment for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID19 appears to be due to a later, exaggerated, host immune response. This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. Therefore, this study proposes to assess the efficacy of immunomodulatory agents that target dysregulated immune response that drive the severe lung, and other organ, damage. The medications investigated for efficacy in this trial are Baricitinib and Ravulizumab.
NCT04399798 ↗	Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial	Not yet recruiting	IRCCS Policlinico S. Matteo	Phase 2	2020-05-15	The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.

Clinical Trial Conditions for Olumiant

Condition Name

Condition Name for Olumiant
Intervention	Trials
Corona Virus Infection	2
COVID19	2
Emerging Infectious Disease	1
Post-Acute COVID-19 Syndrome	1

Condition MeSH

Condition MeSH for Olumiant
Intervention	Trials
COVID-19	3
Sclerosis	2
Severe Acute Respiratory Syndrome	2
Pneumonia	2

Clinical Trial Locations for Olumiant

Trials by Country

Trials by Country for Olumiant
Location	Trials
United States	12
China	4
Italy	2
Ireland	1
Portugal	1

Trials by US State

Trials by US State for Olumiant
Location	Trials
North Carolina	1
Tennessee	1
Minnesota	1
Georgia	1
Connecticut	1

Clinical Trial Progress for Olumiant

Clinical Trial Phase

Clinical Trial Phase for Olumiant
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Olumiant
Clinical Trial Phase	Trials
Not yet recruiting	7
Recruiting	7
Completed	1

Clinical Trial Sponsors for Olumiant

Sponsor Name

Sponsor Name for Olumiant
Sponsor	Trials
Eli Lilly and Company	2
Peking University People's Hospital	1
ASST Fatebenefratelli Sacco	1

Sponsor Type

Sponsor Type for Olumiant
Sponsor	Trials
Other	32
Industry	4

OLUMIANT (Baricitinib): Clinical Trials Update, Market Analysis, and Projections

Introduction to OLUMIANT

OLUMIANT, also known as baricitinib, is a Janus kinase (JAK) inhibitor developed by Incyte and licensed to Eli Lilly. It is approved for the treatment of moderate to severe rheumatoid arthritis (RA) and moderate to severe atopic dermatitis in various countries, including the U.S., the European Union, and Japan[3].

Clinical Trials Update

Rheumatoid Arthritis (RA) Trials

OLUMIANT was approved by the FDA for RA based on evidence from four clinical trials involving 2456 patients. These trials demonstrated the efficacy of baricitinib in improving arthritis symptoms, as measured by the ACR20 response (a 20% improvement in arthritis symptoms). The trials showed that patients treated with baricitinib had a significantly higher ACR20 response rate compared to those receiving placebo or methotrexate alone[4].

Systemic Lupus Erythematosus (SLE) Trials

Eli Lilly and Incyte announced the discontinuation of the Phase 3 development program for OLUMIANT in adults with active systemic lupus erythematosus (SLE) due to mixed results. While the SLE-BRAVE-I trial met its primary endpoint, showing a statistically significant reduction in disease activity, the SLE-BRAVE-II trial did not meet its primary endpoint. Despite this, Lilly plans to analyze the data to advance the understanding of SLE and publish the findings in the future[1].

Atopic Dermatitis Trials

OLUMIANT has been evaluated in eight clinical trials for atopic dermatitis, including six double-blind, randomized, placebo-controlled studies and two long-term extension studies. These trials demonstrated the efficacy and safety of OLUMIANT in patients with moderate-to-severe atopic dermatitis who had an inadequate response to topical prescription therapies. However, there is ongoing discussion with the FDA regarding the indicated population, which may lead to a Complete Response Letter (CRL)[1].

Alopecia Areata Trials

In addition to its approved indications, OLUMIANT is being investigated for the treatment of alopecia areata. Pivotal Phase 3 studies showed that nearly 40% of adults with severe alopecia areata who took OLUMIANT 4 mg achieved at least 80% scalp hair coverage at 52 weeks, along with significant eyelash and eyebrow hair regrowth[3].

Market Analysis

Competitive Landscape

OLUMIANT entered the RA market as the second oral JAK inhibitor, following Pfizer's Xeljanz (tofacitinib). It competes with other JAK inhibitors such as AbbVie's upadacitinib and Gilead/Galapagos' filgotinib, which have shown promising results in clinical trials. However, upadacitinib and filgotinib were expected to launch later, giving OLUMIANT an initial competitive advantage[2].

Market Forecast

GlobalData predicts that OLUMIANT will establish itself in the RA market, generating significant sales. By 2025, OLUMIANT is expected to achieve sales of $768.9 million in the U.S. alone. The RA market is highly competitive, with anti-TNF therapies being highly effective, but the introduction of JAK inhibitors and biosimilars is changing market dynamics[2].

Global Prevalence and Market Trends

Rheumatoid arthritis affects over six million individuals in the major markets (U.S., France, Germany, Italy, Spain, UK, Japan, and Australia), with this number expected to grow to nearly seven million by 2025. The market is shifting with the introduction of biosimilars, novel biologics, and oral therapies like JAK inhibitors, which will impact the competitive landscape and market revenue[5].

Safety and Efficacy Profile

Safety Concerns

The FDA approval of OLUMIANT comes with a boxed warning for the risk of serious infections, malignancies, and thrombosis. Patients must have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies before being prescribed OLUMIANT. The safety profile of OLUMIANT has been consistent across various clinical trials, but these warnings highlight the need for careful patient selection and monitoring[2].

Efficacy in Different Indications

• Rheumatoid Arthritis: OLUMIANT has shown significant efficacy in improving arthritis symptoms and slowing disease progression.
• Atopic Dermatitis: It has been effective in treating moderate-to-severe atopic dermatitis in patients who have not responded adequately to topical therapies.
• Alopecia Areata: Clinical trials have demonstrated promising results in hair regrowth for patients with severe alopecia areata[1][3].

Regulatory Updates

FDA Discussions for Atopic Dermatitis

Lilly is in ongoing discussions with the FDA regarding the supplemental new drug application (sNDA) for OLUMIANT in atopic dermatitis. The lack of alignment with the FDA on the indicated population may lead to a Complete Response Letter (CRL), which could delay or alter the approval process[1].

Global Approvals

OLUMIANT has received marketing authorization for various indications in over 75 countries, including the treatment of hospitalized patients with COVID-19 in multiple countries. Its approval in the European Union and Japan for atopic dermatitis highlights its global reach and acceptance[3].

Key Takeaways

• Clinical Trials: OLUMIANT has shown mixed results in SLE trials but significant efficacy in RA and atopic dermatitis trials.
• Market Position: It competes in a crowded RA market but is expected to generate substantial sales by 2025.
• Safety Profile: The drug comes with a boxed warning for serious infections, malignancies, and thrombosis.
• Global Reach: Approved in over 75 countries for various indications, including RA, atopic dermatitis, and COVID-19.

FAQs

What is OLUMIANT used for?

OLUMIANT (baricitinib) is used for the treatment of moderate to severe rheumatoid arthritis (RA) and moderate to severe atopic dermatitis. It is also being investigated for other conditions such as systemic lupus erythematosus (SLE) and alopecia areata.

What are the safety concerns associated with OLUMIANT?

OLUMIANT comes with a boxed warning for the risk of serious infections, malignancies, and thrombosis. Patients must have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies before being prescribed OLUMIANT.

How does OLUMIANT compare to other JAK inhibitors?

OLUMIANT competes with other JAK inhibitors like Pfizer's Xeljanz (tofacitinib), AbbVie's upadacitinib, and Gilead/Galapagos' filgotinib. While it has an initial market advantage, upadacitinib and filgotinib offer a potentially better safety profile by specifically inhibiting JAK1.

What is the current status of OLUMIANT's Phase 3 SLE program?

The Phase 3 SLE development program for OLUMIANT has been discontinued due to mixed results from the SLE-BRAVE-I and II trials. However, Lilly plans to analyze the data to advance the understanding of SLE.

How many patients have been treated with OLUMIANT worldwide?

To date, more than 343,000 patients have been treated with OLUMIANT worldwide across its approved indications.

Sources

1. PR Newswire: Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis[1].
2. Pharmaceutical Technology: Eli Lilly's Olumiant: how will it far among JAK inhibitors?[2].
3. PR Newswire: Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4 mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies[3].
4. FDA: Drug Trials Snapshots: OLUMIANT[4].
5. GlobalData: PharmaPoint: Rheumatoid Arthritis – Global Drug Forecast and Market Analysis to 2025[5].