Delving into the Latest Updates on BI-655064 with Synapse

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Start Date16 May 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT02331277

/ CompletedPhase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Doses of BI 655064 in Healthy Chinese Male Volunteers (Randomised, Double-blind, Placebo-controlled, Clinical Phase I Study)

The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.
The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

Start Date01 Sep 2015

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with BI-655064

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100 Translational Medicine associated with BI-655064

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100 Patents (Medical) associated with BI-655064

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8

Literatures (Medical) associated with BI-655064

01 Jun 2025·Arthritis & Rheumatology

Outcome of Patients With Lupus Nephritis Treated With an Anti‐CD40 Monoclonal Antibody According to Kidney Biopsy Features

Article

Author: Uzzo, Martina ; Bajema, Ingeborg ; Schumacher, Helmut ; Jayne, David ; Steffgen, Juergen ; Deutschel, Simone

Objective:

A phase 2 trial tested different doses of the anti‐CD40 monoclonal antibody BI 655064 as an add‐on therapy to the standard of care in patients with class III or IV lupus nephritis (LN) with active disease. A post hoc analysis showed a potential benefit of the higher tested doses (180 and 240 mg) versus a low dose (120 mg) or placebo. We investigated whether the treatment effect of BI 655064 on kidney outcomes may be modified by the presence of glomerular monocytes, a target for this drug with a well‐known role in LN pathogenesis.

Methods:

One hundred one renal biopsies of patients with LN enrolled in the BI 655064 trial were scored centrally. The estimated glomerular filtration rate (eGFR), spot urine protein/urine creatinine ratio (UP/UC), and complete renal response (CRR) were evaluated over 52 weeks. Patients were divided according to a “better” or “worse” performance than the average of all patients in the cohort, predicted by a mixed model for repeated measurements. Logistic regression models adjusted for potential confounders were used to assess the association between different treatment doses and outcomes according to the presence or absence of monocytes.

Results:

A higher BI 655064 dose (180 or 240 mg) was associated with better outcomes of UP/UC and CRR when glomerular monocytes were present in kidney biopsy samples (odds ratio [OR] 3.66 [95% confidence interval (CI) 1.09–12.3], P = 0.04; OR 4.58 [95% CI 1.24–16.9], P = 0.02). A trend toward improved eGFR was also observed in these patients (at 52 weeks, P = 0.08).

Conclusion:

In LN kidney biopsy samples with glomerular monocytes, high‐dose BI 655064 treatment improved proteinuria at 52 weeks and resulted in a higher CRR compared to biopsy samples without glomerular monocytes. Histologic features may guide the choice of treatment for individual patients with LN.image

01 Apr 2025·LUPUS

Two-year treatment experience with BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: An exploratory, phase II maintenance trial

Article

Author: Steffgen, Jürgen ; Furie, Richard ; Wu, Jing ; Romero-Diaz, Juanita ; Fagan, Nora ; Noppakun, Kajohnsak ; Jayne, David R ; Avihingsanon, Yingyos ; Boumpas, Dimitrios T ; Revollo, Ivette

Objective:

To evaluate the long-term efficacy and safety of different doses of BI 655064 versus placebo added to standard of care during maintenance treatment for lupus nephritis (LN).

Methods:

1293.13 was an exploratory, phase II maintenance trial. Patients were eligible for entry if they had completed 1 year of randomised treatment with BI 655064 (120, 180 or 240 mg) or placebo in the 1293.10 trial, responded to treatment at Year 1 (complete renal response [CRR], partial renal response or urinary protein/creatinine ratio ≤1) and consented to continue treatment. The primary endpoint was the proportion of patients with CRR without renal flares at Year 2. Secondary endpoints included change from baseline in Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) scores and safety/tolerability.

Results:

69/121 patients (57.0%) from the 1293.10 trial entered 1293.13. The adjusted proportion of patients with CRR decreased in all groups between Year 1 (BI 655064: 53.4%–72.7%; placebo: 71.4%) and Year 2 (BI 655064: 48.2%–59.5%; placebo: 57.5%). At Year 2, mean decreases in total SELENA-SLEDAI scores were greatest with BI 655064 240 mg (−10.6 points), followed by 120 mg (−8.9 points), 180 mg (−7.2 points) and placebo (−5.3 points). SELENA-SLEDAI non-renal scores decreased at Year 1 (BI 655064: −3.0 to −3.4; placebo: −1.8); this pattern remained with BI 655064 during Year 2 (−2.4 to −4.1), whereas placebo returned to near-baseline scores (−0.4). Over 2 years of treatment, almost all patients (97.1%) experienced ≥1 adverse event (AE). Compared with the other groups, higher rates of serious AEs (42.9% vs 23.1%–33.3%)—mainly driven by serious infections (23.8% vs 7.7%–14.3%)—and severe AEs (47.6% vs 13.3%–28.6%) were reported with BI 655064 240 mg.

Conclusions:

This exploratory, phase II maintenance trial failed to demonstrate the benefits of BI 655064 on renal outcomes in the treatment of LN. However, some benefits in total and non-renal SELENA-SLEDAI scores were observed.

01 Nov 2023·Arthritis & rheumatology (Hoboken, N.J.)

Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti‐CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double‐Blind, Placebo‐Controlled, Phase II Trial

Article

Author: Gomez, Harold Michael ; Steffgen, Jürgen ; Jayne, David R. ; Avihingsanon, Yingyos ; Satirapoj, Bancha ; Recto, Rhona ; Noppakun, Kajohnsak ; Fagan, Nora ; Wu, Jing ; Amano, Hirofumi ; Naumnik, Beata ; Revollo, Ivette ; Chawanasuntorapoj, Ratana ; Bajema, Ingeborg ; Madero, Magdalena ; Romero‐Diaz, Juanita ; Boumpas, Dimitrios T. ; Visvanathan, Sudha ; Furie, Richard

Objective:

To characterize its dose‐response relationship, BI 655064 (an anti‐CD40 monoclonal antibody) was tested as an add‐on to mycophenolate and glucocorticoids in patients with active lupus nephritis (LN).

Methods:

A total of 121 patients were randomized (2:1:1:2) to receive placebo or BI 655064 120, 180, or 240 mg and received a weekly loading dose for 3 weeks followed by dosing every 2 weeks for the 120 and 180 mg groups, and 120 mg weekly for the 240 mg group. The primary endpoint was complete renal response (CRR) at week 52. Secondary endpoints included CRR at week 26.

Results:

A dose‐response relationship with CRR at week 52 was not shown (BI 655064 120 mg, 38.3%; 180 mg, 45.0%; 240 mg, 44.6%; placebo, 48.3%). At week 26, 28.6% (120 mg), 50.0% (180 mg), 35.0% (240 mg), and 37.5% (placebo) achieved CRR. The unexpected high placebo response prompted a post hoc analysis evaluating confirmed CRR (cCRR, at weeks 46 and 52). cCRR was achieved in 22.5% (120 mg), 44.3% (180 mg), 38.2% (240 mg), and 29.1% (placebo) of patients. Most patients reported ≥1 adverse event (BI 655064, 85.7–95.0%; placebo, 97.5%), most frequently infections and infestations (BI 655064 61.9–75.0%; placebo 60%). Compared with other groups, higher rates of serious (20% vs. 7.5–10%) and severe infections (10% vs. 4.8–5.0%) were reported with 240 mg BI 655064.

Conclusion:

The trial failed to demonstrate a dose‐response relationship for the primary CRR endpoint. Post hoc analyses suggest a potential benefit of BI 655064 180 mg in patients with active LN.

1

News (Medical) associated with BI-655064

07 Mar 2016

·www.biospace.com

AbbVie Coughs Up $595 Million+ for Boehringer Ingelheim’s Psoriasis and Crohn’s Drugs

March 7, 2016 By Mark Terry , BioSpace.com Breaking News Staff North Chicago, Ill.-based AbbVie and Germany-based Boehringer Ingelheim today that they have inked a global collaboration deal to develop and market BI 655066 for psoriasis . AbbVie is paying Boehringer Ingelheim $595 million upfront with additional development and regulatory milestones and royalties if the product makes it to market. BI 655066 is an anti-IL-23 monoclonal biologic antibody that is currently being studied for psoriasis in a Phase III clinical trial. It is also in a Phase II trial for Crohn’s disease and asthma, and is expected to start a Phase II trial for psoriatic arthritis. In addition to BI 655066, AbbVie gained the rights to BI 655064, an anti-CD-40 antibody that is currently in Phase I development. It is being studied as a potential treatment for lupus nephritis, Crohn’s disease and ulcerative colitis. Its safety and efficacy is still being investigated. “This collaboration positions BI 655066 as AbbVie’s lead investigational compound in psoriasis, complementing our robust immunology pipeline,” Michael Severino , AbbVie’s executive vice president and chief scientific officer, said in a statement. “Our expertise in developing and commercializing the world’s leading biologic, combined with Boehringer Ingelheim’s clinical success to-date will enable us to offer patients a new treatment options with the potential to meaningfully improve the standard of care.”Partly in response to the deal, AbbVie lowered its 2016 earnings guidance to exclude one-time items related to the agreement. In January, the company projected profit per share of $4.90 to $5.10. Now the range has dropped to $4.82 to $5.02 per share. “We have a long track record in immunology through our experience with Humira,” said Severino to Bloomberg Business , “and it’s an area we remain committed to.” He went on to note that Boehringer’s drug data “are truly spectacular and have real potential for differentiation, representing a new treatment option for patients.” Bloomberg also notes that this is a particularly competitive area. AbbVie’s Humira is dominant with $14 billion in sales in 2015. Johnson & Johnson and Merck & Co. are also working on anti-IL-23 products and Novartis AG ’s IL-17 drug for psoriasis was recently approved. Eli Lilly & Co. and AstraZeneca are also working on IL-17 inhibitors. However, Humira faces competition from biosimilars, which may be why AbbVie is pushing for a viable backup. There were also rumors circulating last week that AbbVie and Boehringer were in talks for a cancer partnership. In May, AbbVie acquired Pharmacyclics , which markets Imbruvica (ibrutinib), a first-in-class BTK-inhibitor for the treatment of hematologic cancers. Boehringer has focused on lung cancer drugs. It markets Giotrif for non small-cell lung cancer, and Vargatef for later-stage patients, and has pipeline products for lung and bowel cancer.

Phase 1Phase 2Drug ApprovalLicense out/inAcquisition

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 2	United States	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Japan	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Australia	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Canada	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Czechia	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	France	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Germany	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Greece	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Hong Kong	Boehringer Ingelheim GmbH	16 May 2016
Lupus Nephritis	Phase 2	Italy	Boehringer Ingelheim GmbH	16 May 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01751776 (CTgov)	Phase 1	Rheumatoid Arthritis	107	BI 655064 (Part 1, BI 655064 80mg (HV))	jnrpsvtadc(sakvfblkug) = yzrqvnjvxg kvkcpkxxqo (numcvbrfnu, 492) View more	-	21 Mar 2024
				BI 655064 (Part 1, BI 655064 120mg (HV))	jnrpsvtadc(sakvfblkug) = kuyzpixtze kvkcpkxxqo (numcvbrfnu, 29.5) View more
NCT02009761 (CTgov)	Phase 1	Purpura, Thrombocytopenic, Idiopathic	6	BI 655064	vwaafwinoc = qodhcfnoqa gvisdxwrjs (cpehubeazl, khahbsylnc - uhfjotyoqi) View more	-	15 Mar 2024
NCT02770170 (Phase II Trial, Pubmed \| Arthritis Rheumatol)	Phase 2	Lupus Nephritis Add-on anti-CD40 monoclonal antibody	121	BI 655064 120 mg	zccnhodsml(wmupqaxikr) = arcfaokreu bxwwnhqvty (eawmksgsbt ) View more	Negative	01 Nov 2023
				BI 655064 180 mg	zccnhodsml(wmupqaxikr) = pxnbeusxra bxwwnhqvty (eawmksgsbt ) View more
NCT02331277 (CTgov)	Phase 1	-	12	Placebo (Placebo)	vmdkpysjaj = fhronctvaz scftyjlfrs (ixvjqefduv, edkmuoausr - jxlitufhqv) View more	-	21 Aug 2023
				BI 655064 (BI 655064)	vmdkpysjaj = nlrsyblpvu scftyjlfrs (ixvjqefduv, boirhqqgld - tkjprjrxda) View more
NCT01917916 (CTgov)	Phase 1	-	64	BI 655064 (BI 655064 Dose Group 1 - 80 mg)	wjyomlehzz = oeavvklbxk odphazgbpr (ukffrqqlqm, qpcvwguokk - fxbeqlkzux) View more	-	09 Aug 2023
				BI 655064 (BI 655064 Dose Group 2 - 120 mg)	wjyomlehzz = cwmnnaqwmm odphazgbpr (ukffrqqlqm, itxsaivdix - ysxbxiqitq) View more
NCT03385564 (CTgov)	Phase 2	Lupus Nephritis	69	BI 655064 (BI 655064 120 mg)	caszzvyauz = lyhjwpqdlk orpgcsqudj (lyiiklfiwb, stgxbizpcd - gfkjrnhnhq) View more	-	13 Jul 2022
				BI 655064 (BI 655064 180 mg)	caszzvyauz = dtmqgcayfz orpgcsqudj (lyiiklfiwb, oqscbxcdzz - dryyjkxicl) View more
NCT02770170 (FC 049 \| Phase II Trial, CTgov)	Phase 2	Lupus Nephritis	121	Placebo	sephppfqpq = tkavjcdcjr xcemqgsizy (gvgxztxojg, mbzscefkog - ocpvxwyyoj) View more	-	12 Jul 2021
NCT02770170 (FC 049, ERA2021)	Phase 2	Lupus Nephritis Add-on ISN/RPS class III or IV (±V) renal biopsy \| protein/creatinine ratio	121	BI 655064 180 mg	ptvcwrjduy(scofozxggg) = ntrewwlwgg zjpqtagpxm (xqygjzdgbm ) View more	Negative	29 May 2021
				Placebo	uwfhgjzkov(qdfmpcogqd) = hwjfdlfctp wsryqchaxv (iaqrfpwuef ) View more
NCT01751776 (Pubmed \| Arthritis Rheumatol \| Ann Rheum Dis) Manual	Phase 2	Rheumatoid Arthritis	67	BI 655064	qxftzxfsvy(fwameiycsn) = wjvglhhlgf jmqxmhvfhk (brnvoihrzj )	Negative	01 Jun 2019
				Placebo	qxftzxfsvy(fwameiycsn) = vtbcuapljf jmqxmhvfhk (brnvoihrzj )
EULAR2016	Not Applicable	Rheumatoid Arthritis Add-on CD40 receptor occupancy \| CD40L-induced CD54 upregulation \| CRP ... View more	67	BI 655064	mvhpzbvmzc(hhmjbqypau) = oxtqqecjoe qyyjxfkplz (zkdpxtwnad ) View more	-	08 Jun 2016
				Placebo	mvhpzbvmzc(hhmjbqypau) = lbgbuigceb qyyjxfkplz (zkdpxtwnad ) View more

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